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Meta-Analysis
. 2024 Oct 9;10(10):CD013344.
doi: 10.1002/14651858.CD013344.pub2.

Interventions for BK virus infection in kidney transplant recipients

Zainab Wajih  1 , Krishna M Karpe  2 , Giles D Walters  2
Affiliations
Meta-Analysis

Interventions for BK virus infection in kidney transplant recipients

Zainab Wajih et al. Cochrane Database Syst Rev. .

Abstract

Background: BK virus-associated nephropathy (BKVAN), caused by infection with or reactivation of BK virus, remains a challenge in kidney transplantation. Screening is recommended for all kidney transplant recipients. For those with clinically significant infection, reduction of immunosuppression is the cornerstone of management. There is no specific antiviral or immunomodulatory therapy sufficiently effective for routine use.

Objectives: This review aimed to examine the benefits and harms of interventions for BK virus infection in kidney transplant recipients.

Search methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 5 September 2024 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal and ClinicalTrials.gov.

Selection criteria: All randomised controlled trials (RCTs) and cohort studies investigating any intervention for the treatment or prevention of BKVAN for kidney transplant recipients.

Data collection and analysis: Two authors independently assessed the study quality and extracted data. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) and 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Main results: Twelve RCTs (2669 randomised participants) were included. Six studies were undertaken in single centres, and six were multicentre studies; two of these were international studies. The ages of those participating ranged from 44 to 57 years. The length of follow-up ranged from three months to five years. All studies included people with a kidney transplant, and three studies included people with signs of BK viraemia. Studies were heterogeneous in terms of the type of interventions and outcomes assessed. The overall risk of bias was low or unclear. Intensive screening for the early detection of BK viraemia or BK viruria prevents graft loss (1 study, 908 participants: RR 0.00, 95% CI 0.00 to 0.05) and decreases the presence of decoy cells and viraemia at 12 months (1 study, 908 participants: RR 0.06, 95% CI 0.03 to 0.11) compared to routine care (high certainty evidence). No other outcomes were reported. Compared to placebo, fluoroquinolones may slightly reduce the risk of graft loss (3 studies, 393 participants: RR 0.37, CI 0.09 to 1.57; I2 = 0%; low certainty evidence), probably makes little or no difference to donor-specific antibodies (DSA), may make little or no difference to BK viraemia and death, had uncertain effects on BKVAN and malignancy, but may increase the risk of tendonitis (2 studies, 193 participants: RR 5.66, CI 1.02 to 31.32; I2 = 0%; low certainty evidence). Compared to tacrolimus (TAC), cyclosporin (CSA) probably makes little or no difference to graft loss and death, may make little or no difference to BKVAN and malignancy, but probably decreases BK viraemia (2 studies, 263 participants: RR 0.61, 95% CI 0.26 to 1.41; I2 = 38%) and probably reduces the risk of new-onset diabetes after transplantation (1 study, 200 participants: RR 0.41, 95% CI 0.12 to 1.35) (both moderate certainty evidence). Compared to azathioprine, mycophenolate mofetil (MMF) probably makes little or no difference to graft loss and BK viraemia but probably reduces the risk of death (1 study, 133 participants: RR 0.43, 95% CI 0.16 to 1.16) and malignancy (1 study, 199 participants: RR 0.43, 95% CI 0.16 to 1.16) (both moderate certainty evidence). Compared to mycophenolate sodium (MPS), CSA has uncertain effects on graft loss and death, may make little or no difference to BK viraemia, but may reduce BKVAN (1 study, 224 participants: RR 0.06, 95% CI 0.00 to 1.20; low certainty evidence). Compared to immunosuppression dose reduction, MMF or TAC conversion to everolimus or sirolimus may make little or no difference to graft loss, BK viraemia or BKVAN (low certainty evidence). TAC conversion to sirolimus probably results in more people having a reduced BK viral load (< 600 copies/mL) than immunosuppression reduction (1 study, 30 participants: RR 1.31, 95% CI 0.90 to 1.89; moderate certainty evidence). Compared to MPS, everolimus had uncertain effects on graft loss and BK viraemia, may reduce BKVAN (1 study, 135 participants: 0.06, 95% CI 0.00 to 1.11) and may increase the risk of death (1 study, 135 participants: RR 3.71, 95% CI 0.20 to 67.35) (both low certainty evidence). Compared to CSA, everolimus may make little or no difference to BK viraemia, has uncertain effects on graft loss and BKVAN, but may increase the risk of death (1 study, 185 participants: RR 3.71, 95% CI 0.42 to 32.55; low certainty evidence). Compared to immunosuppression reduction, the leflunomide derivative FK778 may make little or no difference to graft loss, probably results in a greater reduction in plasma BK viral load (1 study, 44 participants: -0.60 copies/µL, 95% CI -1.22 to 0.02; moderate certainty evidence), but had uncertain effects on BKVAN and malignancy. Aggravated hypertension may be increased with KF778 (1 study, 46 participants: RR 8.23, 95% CI 0.50 to 135.40; low certainty evidence). There were no deaths in either group.

Authors' conclusions: Intense monitoring early after transplantation for BK viruria and BK viraemia is effective in improving BK virus infection outcomes as it helps with early detection of the infection and allows for a timely reduction in immunosuppression reduction. There is insufficient evidence to support any other intervention for BK virus infection in kidney transplant recipients.

Trial registration: ClinicalTrials.gov NCT00104338 NCT01353339 NCT01034176 NCT01789203 NCT01624948 NCT00724022 NCT01860183 NCT01377467 NCT00251004 NCT04605484 NCT02495077 NCT04294472 NCT05385432 NCT05511779 NCT06059664 NCT06114953.

PubMed Disclaimer

Conflict of interest statement

  1. Zainab Wajih: no relevant interests were disclosed

  2. Krishna Karpe: no relevant interests were disclosed

  3. Giles Walters: no relevant interests were disclosed

Figures

1
1
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Intensive screening versus control (routine care), Outcome 1: Graft loss
1.2
1.2. Analysis
Comparison 1: Intensive screening versus control (routine care), Outcome 2: Persistence of decoy cells/viraemia at 12 months
2.1
2.1. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 1: Graft loss
2.2
2.2. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 2: Acute rejection
2.3
2.3. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 3: Serum creatinine [µmol/L]
2.4
2.4. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 4: BK viraemia at end of study (8 to 12 months)
2.5
2.5. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 5: Sustained BK viraemia
2.6
2.6. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 6: BK viruria
2.7
2.7. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 7: Viral load reduction at 6 months
2.8
2.8. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 8: Viral load > 10,000 copies/mL
2.9
2.9. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 9: Initial BK titre copies/L
2.10
2.10. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 10: BK virus‐associated nephropathy (BKVAN)
2.11
2.11. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 11: Donor‐specific antibodies
2.12
2.12. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 12: Death
2.13
2.13. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 13: Malignancy
2.14
2.14. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 14: Infection
2.15
2.15. Analysis
Comparison 2: Fluroquinolones versus placebo, Outcome 15: Therapy‐related adverse events: tendonitis
3.1
3.1. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 1: Graft loss
3.2
3.2. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 2: Rejection
3.3
3.3. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 3: Serum creatinine [mg/dL]
3.4
3.4. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 4: eGFR [mL/min]
3.5
3.5. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 5: BK viraemia
3.6
3.6. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 6: BK virus‐associated nephropathy (BKVAN)
3.7
3.7. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 7: Death
3.8
3.8. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 8: Patient survival at 5 years
3.9
3.9. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 9: Malignancy
3.10
3.10. Analysis
Comparison 3: Cyclosporin (CSA) versus tacrolimus (TAC), Outcome 10: Therapy‐related adverse events: new‐onset diabetes after transplantation (NODAT)
4.1
4.1. Analysis
Comparison 4: Mycophenolate mofitel (MMF) versus azathioprine (AZA), Outcome 1: Graft loss
4.2
4.2. Analysis
Comparison 4: Mycophenolate mofitel (MMF) versus azathioprine (AZA), Outcome 2: Rejection
4.3
4.3. Analysis
Comparison 4: Mycophenolate mofitel (MMF) versus azathioprine (AZA), Outcome 3: BK viraemia
4.4
4.4. Analysis
Comparison 4: Mycophenolate mofitel (MMF) versus azathioprine (AZA), Outcome 4: Death
4.5
4.5. Analysis
Comparison 4: Mycophenolate mofitel (MMF) versus azathioprine (AZA), Outcome 5: Malignancy
5.1
5.1. Analysis
Comparison 5: Cyclosporin (CSA) versus mycophenolate sodium (MPS), Outcome 1: Graft loss
5.2
5.2. Analysis
Comparison 5: Cyclosporin (CSA) versus mycophenolate sodium (MPS), Outcome 2: Rejection
5.3
5.3. Analysis
Comparison 5: Cyclosporin (CSA) versus mycophenolate sodium (MPS), Outcome 3: BK viraemia
5.4
5.4. Analysis
Comparison 5: Cyclosporin (CSA) versus mycophenolate sodium (MPS), Outcome 4: BK viruria
5.5
5.5. Analysis
Comparison 5: Cyclosporin (CSA) versus mycophenolate sodium (MPS), Outcome 5: BK virus‐associated nephropathy (BKVAN)
5.6
5.6. Analysis
Comparison 5: Cyclosporin (CSA) versus mycophenolate sodium (MPS), Outcome 6: Death
6.1
6.1. Analysis
Comparison 6: Mycophenolate mofetil (MMF) conversion to everolimus (EVL) versus MMF dose reduction, Outcome 1: Rejection
6.2
6.2. Analysis
Comparison 6: Mycophenolate mofetil (MMF) conversion to everolimus (EVL) versus MMF dose reduction, Outcome 2: BK viraemia at 12 months
6.3
6.3. Analysis
Comparison 6: Mycophenolate mofetil (MMF) conversion to everolimus (EVL) versus MMF dose reduction, Outcome 3: Reduction of BK viruria by 50%
6.4
6.4. Analysis
Comparison 6: Mycophenolate mofetil (MMF) conversion to everolimus (EVL) versus MMF dose reduction, Outcome 4: BK virus‐associated nepropathy (BKVAN)
7.1
7.1. Analysis
Comparison 7: Conversion to tacrolimus (TAC) plus everolimus (TAC/EVL) versus TAC plus mycophenolate mofetil (TAC/MMF), Outcome 1: Graft loss
7.2
7.2. Analysis
Comparison 7: Conversion to tacrolimus (TAC) plus everolimus (TAC/EVL) versus TAC plus mycophenolate mofetil (TAC/MMF), Outcome 2: BK viraemia
7.3
7.3. Analysis
Comparison 7: Conversion to tacrolimus (TAC) plus everolimus (TAC/EVL) versus TAC plus mycophenolate mofetil (TAC/MMF), Outcome 3: BK virus‐associated nephropathy (BKVAN)
8.1
8.1. Analysis
Comparison 8: Tacrolimus (TAC) conversion to sirolimus (SRL) versus immunosuppression reduction, Outcome 1: BK viral load < 600 copies/mL
8.2
8.2. Analysis
Comparison 8: Tacrolimus (TAC) conversion to sirolimus (SRL) versus immunosuppression reduction, Outcome 2: BK virus‐associated nephropathy (BKVAN)
9.1
9.1. Analysis
Comparison 9: Everolimus (EVL) versus mycophenolate sodium (MPS), Outcome 1: Graft loss
9.2
9.2. Analysis
Comparison 9: Everolimus (EVL) versus mycophenolate sodium (MPS), Outcome 2: Rejection
9.3
9.3. Analysis
Comparison 9: Everolimus (EVL) versus mycophenolate sodium (MPS), Outcome 3: BK viraemia
9.4
9.4. Analysis
Comparison 9: Everolimus (EVL) versus mycophenolate sodium (MPS), Outcome 4: BK viruria
9.5
9.5. Analysis
Comparison 9: Everolimus (EVL) versus mycophenolate sodium (MPS), Outcome 5: BK virus‐associated nephropathy (BKVAN)
9.6
9.6. Analysis
Comparison 9: Everolimus (EVL) versus mycophenolate sodium (MPS), Outcome 6: Death
10.1
10.1. Analysis
Comparison 10: Everolimus (EVL) versus cyclosporin (CSA), Outcome 1: Graft loss
10.2
10.2. Analysis
Comparison 10: Everolimus (EVL) versus cyclosporin (CSA), Outcome 2: Rejection
10.3
10.3. Analysis
Comparison 10: Everolimus (EVL) versus cyclosporin (CSA), Outcome 3: BK viraemia
10.4
10.4. Analysis
Comparison 10: Everolimus (EVL) versus cyclosporin (CSA), Outcome 4: BK viruria
10.5
10.5. Analysis
Comparison 10: Everolimus (EVL) versus cyclosporin (CSA), Outcome 5: BK virus‐associated nephropathy (BKVAN)
10.6
10.6. Analysis
Comparison 10: Everolimus (EVL) versus cyclosporin (CSA), Outcome 6: Death
11.1
11.1. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 1: Graft loss
11.2
11.2. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 2: Change in serum creatinine [mg/dL]
11.3
11.3. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 3: Serum creatinine increase
11.4
11.4. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 4: Change in creatinine clearance [mL/min]
11.5
11.5. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 5: Change in plasma BK viral load [copies/µL]
11.6
11.6. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 6: Change in urine BK viral load [copies/µL]
11.7
11.7. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 7: Biopsy‐confirmed acute rejection (BKVAN)
11.8
11.8. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 8: Death
11.9
11.9. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 9: Malignancy: skin cancer
11.10
11.10. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 10: Infection
11.11
11.11. Analysis
Comparison 11: Leflunomide derivative (FK778) versus control (reduced immunosuppression), Outcome 11: Therapy‐related adverse events
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Brennan 2005 {published data only}
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    1. Agha IA, Hardinger KL, Bohl D, Ansari A, Dyk P, Koch M, et al. Preemptive withdrawal of AZA or MMF prevents progression of BK viremia to BK nephropathy: a prospective randomized controlled trial of BK virus infection after renal transplantation [abstract no: 150]. American Journal of Transplantation 2004;4(Suppl 8):200. [CENTRAL: CN-00509045]
    1. Bohl DL, Storch GA, Ryschkewitsch C, Gaudreault-Keener M, Schnitzler MA, Major EO, et al. Donor origin of BK virus in renal transplantation and role of HLA C7 in susceptibility to sustained BK viremia. American Journal of Transplantation 2005;5(9):2213-21. [MEDLINE: ] - PubMed
    1. Brennan DC, Agha I, Bohl DL, Schnitzler MA, Hardinger KL, Lockwood M, et al. Incidence of BK with tacrolimus versus cyclosporine and impact of preemptive immunosuppression reduction [Erratum in: Am J Transplant. 2005 Apr;5(4 Pt 1):839]. American Journal of Transplantation 2005;5(3):582-94. [MEDLINE: ] - PubMed
DIRECT TX 2005 {published data only}
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    1. Chadban S, Russ G, Irish A, Eris J. Prospective study of polyomavirus BK viruria and viremia in de novo renal transplantation comparing cyclosporine and tacrolimus: a multivariate analysis [abstract no: 64]. Immunology & Cell Biology 2010;88(6):A21. [EMBASE: 70313678]
    1. Friman S, Tuncer M, Wiecek A, Citterio F, Klinger M, Scheuermann EH, et al. Evaluation of the incidence of glucose metabolism impairments after de novo kidney transplantation using an oral glucose tolerance test [abstract no: 991]. American Journal of Transplantation 2005;5(Suppl 11):408.
    1. Hirsch HH, Tuncer M, Friman S, Wiececk A, Citterio F, Klinger M, et al. Prospective study of polyomavirus BK viruria and viremia in de novo renal transplantation [abstract no: 457]. American Journal of Transplantation 2005;5(Suppl 11):272. [CENTRAL: CN-00676035]
    1. Hirsch HH, Tuncer M, Friman S, Wiecek A, Citterio F, Klinger M, et al. Prospective study of polyomavirus BK viruria and viremia in de novo renal transplantation [abstract no: OR-043]. Transplant International 2005;18(Suppl):11.
Galen 2014 {published data only}
    1. Galen K, West-Thielke P, Huber M, Hetterman E, Benken J, Campara M, et al. A prospective, randomized study of levofloxacin prophylaxis for BK viremia in kidney transplant recipients [abstract no: B1016]. Transplantation 2014;98(Suppl 1):554-5. [EMBASE: 71545398]
Guasch 2010 {published data only}
    1. Guasch A, Roy-Chaudhury P, Woodle ES, Fitzsimmons W, Holman J, First MR. Assessment of efficacy and safety of FK778 in comparison with standard care in renal transplant recipients with untreated BK nephropathy. Transplantation 2010;90(8):891-7. [MEDLINE: ] - PubMed
Humar 2013 {published data only}
    1. Gill JS, Humar A, Fergusson D, Johnston O, House AA, Kim J, et al. Levofloxacin for BK virus prophylaxis in kidney transplantation [abstract no: SA-PO1091]. Journal of the American Society of Nephrology 2014;25(Abstract Suppl):1151A.
    1. Humar A, Gill J, Johnston O, Fergusson D, House AA, Lebel L, et al. Quinolone prophylaxis for the prevention of BK virus infection in kidney transplantation: study protocol for a randomized controlled trial. Trials [Electronic Resource] 2013;14:185. [MEDLINE: ] - PMC - PubMed
    1. Knoll GA, Humar A, Fergusson D, Johnston O, House AA, Kim SJ, et al. Levofloxacin for BK virus prophylaxis following kidney transplantation: a randomized clinical trial. JAMA 2014;312(20):2106-14. [MEDLINE: ] - PubMed
Lee 2014 {published data only}
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MECANO 2009 {published data only}69188731
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    1. Baas MC, Gerdes VE, Ten Berge IJ, Heutinck KM, Florquin S, Meijers JC, et al. Treatment with everolimus is associated with a procoagulant state. Thrombosis Research 2013;132(2):307-11. [MEDLINE: ] - PubMed
    1. Baas MC, Kers J, Florquin S, Van Den Bergh Weerman MA, Ten Berge IJ, Bemelman FF. Prolonged treatment with everolimus does not induce podocyte damage and leaves the glomerular basement membrane intact [abstract no: 967]. American Journal of Transplantation 2011;11(Suppl 2):317. [EMBASE: 70406012]
    1. Baas MC, Kers J, Florquin S, Fijter JW, Heide JJ, den Bergh Weerman MA, et al. Cyclosporine versus everolimus: effects on the glomerulus. Clinical Transplantation 2013;27(4):535-40. [MEDLINE: ] - PubMed
    1. Baas MC, Struijk GH, Moes DJ, den Berk IA, Jonkers RE, Fijter JW, et al. Interstitial pneumonitis caused by everolimus: a case-cohort study in renal transplant recipients. Transplant International 2014;27(5):428-36. [MEDLINE: ] - PubMed
Mohan 2016 {published data only}
    1. Mohan S, Chiles MC, Dadhania D, Lee S, Tanriover B, Crew RJ, et al. mTOR inhibitors in the prevention of BK nephropathy: a randomized clinical pilot study [abstract no: PUB778]. Journal of the American Society of Nephrology 2016;27(Abstract Suppl):1082-3A. [EMBASE: 641134420]
Patel 2019 {published data only}
    1. Patel S, Kuten S, Knight R, Nolte J, Nguyen D, Graviss E, et al. Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: results of a prospective, randomized controlled trial [abstract no: 135]. American Journal of Transplantation 2018;18(Suppl 4):299. [EMBASE: 622280557] - PubMed
    1. Patel SJ, Knight RJ, Kuten SA, Graviss EA, Nguyen DT, Moore LW, et al. Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: results of a prospective, double-blind, randomized, placebo-controlled trial. American Journal of Transplantation 2019;19(6):1831-7. [MEDLINE: ] - PubMed
Renner 2013 {published data only}
    1. Renner FC, Dietrich H, Bulut N, Celik D, Freitag E, Gaertner N, et al. The risk of polyomavirus-associated graft nephropathy is increased by a combined suppression of CD8 and CD4 cell-dependent immune effects. Transplantation Proceedings 2013;45(4):1608-10. [MEDLINE: ] - PubMed
    1. Renner FC, Dietrich H, Bulut N, Celik D, Gaertner ND, Karoui S, et al. The development of BK viremia after renal transplantation is associated with a reduced CD8 cell IL-2 response [abstract no: O-198]. Transplant International 2011;24(Suppl 2):56. [EMBASE: 70527275]
Wali 2008 {published data only}
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Wojciechowski 2017 {published data only}
    1. Webber A, Wojciechowski D, Leung C, Chandran S, Hirose R, Vincenti F. Pharmacodynamic monitoring of NFAT-regulated gene expression and P70S6 kinase activity in kidney transplant patients with BKV infection [abstract no: A31]. Transplantation 2014;98(Suppl 1):880. [EMBASE: 71546539]
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References to studies excluded from this review

Abend 2017 {published data only}
    1. Abend JR, Changala M, Sathe A, Casey F, Kistler A, Chandran S, et al. Correlation of BK virus neutralizing serostatus with the incidence of BK viremia in kidney transplant recipients. Transplantation 2017;101(6):1495-505. [MEDLINE: ] - PubMed
BK‐KIDNI 2013 {published data only}
    1. Ravani P, Hemmelgarn B, Tibbles LA. The BK:KIDNI trial - BK viremia: kinase inhibition to decrease nephropathy intervention trial [abstract no: SA-PO966]. Journal of the American Society of Nephrology 2013;24(Abstract Suppl):847A.
Gatault 2017 {published data only}
    1. Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, et al. Comparison of efficacy and safety of a 4-month post-renal transplant dose reduction of tacrolimus [abstract no: A148]. American Journal of Transplantation 2016;16(Suppl 3):451. [EMBASE: 611699599]
    1. Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, et al. Efficacy and safety of a 4-month post-renal transplant dose reduction of tacrolimus prolonged-release [abstract no: 620.9]. Transplantation 2016;100(7 Suppl 1):S401. [EMBASE: 613005094]
    1. Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, et al. Reduction of extended-release tacrolimus dose in low-immunological-risk kidney transplant recipients increases risk of rejection and appearance of donor-specific-antibodies: a randomized study. American Journal of Transplantation 2017;17(5):1370-9. [MEDLINE: ] - PubMed
HARMONY 2016 {published data only}
    1. Blazquez-Navarro A, Dang-Heine C, Wittenbrink N, Bauer C, Wolk K, Sabat R, et al. BKV, CMV, and EBV interactions and their effect on graft function one year post-renal transplantation: results from a large multi-centre study. EBioMedicine 2018;34:113-21. [MEDLINE: ] - PMC - PubMed
    1. Hugo C, Wiesener MS, Opgenoorth M, Thomusch O. Rabbit-ATG or basiliximab induction for rapid steroid withdrawal after renal transplantation: an open label multicentre, randomized controlled trial [abstract no: HI-OR03]. Journal of the American Society of Nephrology 2016;27(Abstract Suppl):1B. [EMBASE: 641133914] - PubMed
    1. Thomusch O, Wiesener M, Opgenoorth M, Pascher A, Woitas RP, Witzke O, et al. Rabbit-ATG or basiliximab induction for rapid steroid withdrawal after renal transplantation (Harmony): an open-label, multicentre, randomised controlled trial [Erratum in: Lancet. 2017 Feb 25;389(10071):804]. Lancet 2016;388(10063):3006-16. [MEDLINE: ] - PubMed
Pasara 2015 {published data only}
    1. Pasara V, Ljubanovic DG, Knotek M. Effect of mycophenolate mofetil dose on BK virus infection in kidney transplant recipients [abstract no: PUB698]. Journal of the American Society of Nephrology 2015;26(Abstract Suppl):1049A. [EMBASE: 641104298]
Pile 2020 {published data only}
    1. Pile T, Raftery M, Thuraisingham R, Kirwan CJ, Harwood S, Yaqoob MM. Treating posttransplant anemia with erythropoietin improves quality of life but does not affect progression of chronic kidney disease. Experimental & Clinical Transplantation 2020;18(1):27-33. [MEDLINE: ] - PubMed
    1. Pile T, Raftery MJ, Yaqoob M. Treating post transplant anaemia does not affect progression of chronic kidney disease: A pilot randomised controlled trial [abstract no: SA-PO3061]. Journal of the American Society of Nephrology 2010;21(Abstract Suppl):810A.
POSTOP 2014 {published data only}
    1. Bonani M, Brockmann J, Cohen CD, Fehr T, Nocito A, Schiesser M, et al. A randomized open-label clinical trial examining the effect of denosumab on the prevention of 1st-year bone mineral density loss after renal transplantation (POSTOP study; NCT01377467) [abstract no: FP688]. Nephrology Dialysis Transplantation 2012;27(Suppl 2):ii304. [EMBASE: 70766189]
    1. Bonani M, Fehr T, Mueller T, Blum M, Brockmann J, Frey D, et al. Prevention of bone mineral density (BMD) loss after kidney transplantation with the rank ligand inhibitor denosumab (POSTOP study): baseline data, biomarker response and initial safety [abstract]. Swiss Medical Weekly 2014;144(Suppl 208):24S. [EMBASE: 71713909]
    1. Bonani M, Frey D, Brockmann J, Fehr T, Mueller TF, Saleh L, et al. Effect of twice-yearly denosumab on prevention of bone mineral density loss in de novo kidney transplant recipients: a randomized controlled trial. American Journal of Transplantation 2016;16(6):1882-91. [MEDLINE: ] - PubMed
    1. Bonani M, Frey D, Brockmann J, Fehr T, Muller T, Graf N, et al. Denosumab prevents bone mineral density loss in de novo kidney transplant recipients: results from a randomized controlled trial [abstract no: 339]. American Journal of Transplantation 2016;16(Suppl 3):323. [EMBASE: 611700418] - PubMed
    1. Bonani M, Frey D, Brockmann J, Fehr T, Muller T, Graf N, et al. Infections in de novo kidney transplant recipients treated with the RANKL inhibitor denosumab: a post-hoc analysis of the POSTOP clinical trial (NCT01377467) [abstract no: B239]. American Journal of Transplantation 2016;16(Suppl 3):580. [EMBASE: 611699497]
SALAMI 2012 {published data only}2006‐000830‐1194424606
    1. Cherukuri A, Carter C, Smalle N, Hernandez-Fuentes M, Salama A, Clark B, et al. Alemtuzumab induction leads to a peripheral regulatory B cell phenotype that correlates with graft function [abstract no: 204]. American Journal of Transplantation 2011;11(Suppl 2):92. [EMBASE: 70405239]
    1. Cherukuri A, Salama AD, Carter C, Smalle N, McCurtin R, Hewitt EW, et al. An analysis of lymphocyte phenotype after steroid avoidance with either alemtuzumab or basiliximab induction in renal transplantation. American Journal of Transplantation 2012;12(4):919-31. [MEDLINE: ] - PubMed
    1. Cherukuri A, Saundh B, Welberry-Smith M, Giddings E, Lewington A, Newstead C, et al. Alemtuzumab induction is not associated with increased replication of opportunistic viruses after renal transplantation [abstract no: M2]. In: British Transplantation Society (BTS).14th Annual Congress; 2011 Mar 9-11; Bournemouth, UK. 2011.
    1. Cherukuri A, Welberry-Smith M, Saundh B, Hale A, Baker R. Opportunistic viral infections after alemtuzumab induction: Results from a randomized controlled trial (RCT) comparing alemtuzumab and basiliximab induction in kidney transplant recipients (KTRS) [abstract no: B956]. Transplantation 2014;98(Suppl 1):536. [EMBASE: 71545338]
    1. Giddings E, Cherukuri A, Welberry-Smith M, Lewington A, Newstead C, Baker B. Mycophenolate mofetil is well tolerated in a steroid avoidance regime and makes little impact on either GI symptoms or quality of life [abstract no: 56]. In: British Transplantation Society (BTS). 14th Annual Congress; 2011 Mar 9-11; Bournemouth, UK. 2011.
Tedesco‐Silva 2010 {published data only}
    1. Campbell S, Walker R, Pilmore H, Kanellis J, Russ G, Hutchison B, et al. Wound healing events are dose related: a multicenter, prospective study on everolimus in renal transplantation [abstract no: 43]. In: Transplantation Society of Australia & New Zealand (TSANZ). 29th Annual Scientific Meeting; 2011 June 29-Jul 1; Canberra (ACT). 2011:64. [CENTRAL: CN-01657183]
    1. Carmellini M, Garcia V, Wang Z, Vergara M, Escrig C, Russ G. Everolimus de novo with reduced-exposure cyclosporine in renal transplant recipients at high risk of efficacy failure: results of a POST-HOC analysis [abstract no: BO234]. Transplant International 2015;28(Suppl 4):209. [EMBASE: 72111829]
    1. Carmellini M, Garcia V, Wang Z, Vergara M, Russ G. Efficacy of everolimus with reduced-exposure cyclosporine in de novo kidney transplant patients at increased risk for efficacy events: analysis of a randomized trial. Journal of Nephrology 2015;28(5):633-9. [MEDLINE: ] - PubMed
    1. Carmellini M, Garcia V, Wong Z, Vergara M, Escrig C, Russ G. Treatment with everolimus and reduced-exposure cyclosporine is efficacious in de novo renal transplant recipients at increased risk for efficacy failure: post-hoc analysis from the A2309 study [abstract no: D125]. American Journal of Transplantation 2015;15(Suppl 3):D125. [EMBASE: 71954404]
    1. Chadban S, Pilmore H, Russ G, John K, Campbell S, O'Connell P, et al. Everolimus plus reduced-exposure cyclosporin versus mycophenolic acid plus cyclosporin: Long-term follow-up of Australia and New Zealand kidney transplant recipients in the A2309 randomised controlled trial [abstract no: 450.9]. Transplantation 2016;100(7 Suppl 1):S250. [EMBASE: 613005419]
Tong 2000 {published data only}
    1. Tong CY, Bakran A, Peiris JS, Muir P, Herrington CS. The association of viral infection and chronic allograft nephropathy with graft dysfunction after renal transplantation. Transplantation 2002;74(4):576-8. [MEDLINE: ] - PubMed
    1. Tong CY, Bakran A, Williams H, Cheung CY, Peiris JS. Association of human herpesvirus 7 with cytomegalovirus disease in renal transplant recipients. Transplantation 2000;70(1):213-6. [MEDLINE: ] - PubMed
Wong 2004 {published data only}
    1. Wong W, Hirsch HH, Fujimoto K, Pascual M, Doran MT, Delvecchio AM, et al. Thymoglobulin induction therapy does not increase risk of BK virus replication in kidney transplant recipients [abstract no: 141]. American Journal of Transplantation 2004;4(Suppl 8):197. [CENTRAL: CN-00509565]

References to studies awaiting assessment

Chandraker 2024 {published data only}
    1. Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, et al. Posoleucel in kidney transplant recipients with bk viremia: multicenter, randomized, double-blind, placebo-controlled phase 2 trial. Journal of the American Society of Nephrology 2024;35(5):618‐29. [DOI: 10.1681/ASN.0000000000000329] [PMID: ] - DOI - PMC - PubMed
    1. Chandraker AK, Regmi A, Gohh RY, Sharma A, Woodle ES, Ansari MJ, et al. Posoleucel associated with reduction of BK viremia and persistence of BL-reactive T cells in a phase 2 trial [abstract no: SA-OR58]. Journal of the American Society of Nephrology 2023;34:77. [EMBASE: 642700748]
    1. Chandraker AK, Singh M, Regmi A, Ansari MJ, Lonze B, Nair VV, et al. Posoleucel as preemptive therapy for BKV infection in kidney transplant recipients: safety, tolerability and efficacy in a phase 2 trial [abstract no: 310.3]. Transplantation 2022;106(9 Suppl):S192. [EMBASE: 644020870]
    1. Wali RK, Singh M, Wojciechowski D, Ansari MJ, Lonze B, Nair V, et al. Posoleucel as preemptive therapy for BKV infection in kidney transplant recipients: safety and tolerability in a phase 2 trial [abstract no: 387]. American Journal of Transplantation 2022;22(2 Suppl 2):500-1. [DOI: 10.1111/ajt.17072] [EMBASE: 639185874] - DOI
He 2022 {published data only}
    1. He KD, Davis C, Ahn J, Gilligan HM, Tan C. A randomized double-blinded placebo-controlled study to determine efficacy of immunoglobulin therapy to treat BK viremia in renal transplant recipients [abstract no: 1465]. Open Forum Infectious Diseases 2022;9(Suppl 2):S639. [DOI: 10.1093/ofid/ofac492.1292] [EMBASE: 640021023] - DOI
    1. Wojciechowski D, Dadhania D, Tan C, He K, Davis C, Ahn J, et al. Impact of IVIg on the treatment of BKV in kidney transplant recipients [abstract no: B69]. American Journal of Transplantation 2023;23(6 Suppl 1):S787‐8. [DOI: 10.1016/j.ajt.2023.05.014] [EMBASE: 2027909362] - DOI
Hricik 2023 {published data only}
    1. Heeger P, Armstrong B, Alhamad T, Brennan D, Bromberg J, Bunnapradist S, et al. Results of the Ctot19 trial: infliximab (IFX) induction does not impact 2-year outcomes in deceased donor kidney transplant recipients [abstract no: 9002]. American Journal of Transplantation 2022;22(Suppl 2):594. [DOI: 10.1111/ajt.17072] [EMBASE: 639186755] - DOI
    1. Hricik DE, Armstrong B, Alhamad T, Brennan DC, Bromberg JS, Bunnapradist S, et al. Infliximab induction lacks efficacy and increases BK virus infection in deceased donor kidney transplant recipients: results of the CTOT-19 Trial. Journal of the American Society of Nephrology 2023;34(1):145‐59. [DOI: 10.1681/ASN.2022040454] [PMID: ] - DOI - PMC - PubMed
Jordan 2022 {published data only}
    1. Jordan S, Limaye AP, Fischbach B, Sood P, Collette S, Gasink L, et al. A randomized phase 2 study of MAU868 vs placebo to treat BK viremia in kidney transplant recipients [abstract no: 9004]. American Journal of Transplantation 2022;22(Suppl 3):595. [DOI: 10.1111/ajt.17072] [EMBASE: 639186780] - DOI
    1. Jordan SC, Limaye A, Fischbach BV, Sood P, Collette S, Gasink L, et al. A randomized phase 2 study of MAU868 vs. placebo to treat BK viremia in kidney transplant recipients [abstract no: SAOR43]. Journal of the American Society of Nephrology 2022;33:46. [EMBASE: 639545676]
Rasaei 2023 {published data only}20230214057417N1
    1. Rasaei N, Malekmakan L, Gholamabbas G, Abdizadeh P. Comparative study of intravenous immunoglobulin and leflunomide combination therapy with intravenous immunoglobulin single therapy in kidney transplant patients with BK virus infection: single-center clinical trial. Experimental & Clinical Transplantation 2023;21(10):814‐9. [DOI: 10.6002/ect.2023.0071] [PMID: ] - DOI - PubMed
Zheng 2022 {published data only}1800017277
    1. Zheng X, Zhang W, Zhou H, Cao R, Shou Z, Zhang S, et al. A multi-center randomized controlled trial to evaluate efficacy and safety of early conversion to a low-dose calcineurin inhibitor combined with sirolimus in renal transplant patients. Chinese Medical Journal 2023;136(5):607-9. [PMID: ] - PMC - PubMed
    1. Zheng X, Zhang W, Zhou H, Cao R, Shou Z, Zhang S, et al. A randomized controlled trial to evaluate efficacy and safety of early conversion to a low-dose calcineurin inhibitor combined with sirolimus in renal transplant patients. Chinese Medical Journal 2022;135(13):1597‐603. [DOI: 10.1097/CM9.0000000000001866] [PMID: ] - DOI - PMC - PubMed

References to ongoing studies

CTIS2023‐504309‐35‐00 {published data only}2023‐504309‐35‐00
    1. CTIS2023-504309-35-00. Evaluation and promotion of specific adaptative immunity against polyomavirus (BKV) to prevent viral infection after kidney transplantation (BK-VAX project). https://trialsearch.who.int/Trial2.aspx?TrialID=CTIS2023-504309-35-00 2023.
NCT05385432 {published data only}
    1. NCT05385432. Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies (INSTEAD) [Induction in sensitized kidney transplant recipients without preexisting donor-specific antibodies: a randomized multicentre trial between a lymphocyte depleting and basiliximab]. https://clinicaltrials.gov/show/NCT05385432 2022.
NCT05511779 {published data only}2041220056
    1. NCT05511779. Study to confirm of the safety and tolerability of Brincidofovir in subjects with BK virus infection (Viremia) after kidney transplantation. https://clinicaltrials.gov/show/NCT05511779 2022.
NCT06059664 {published data only}
    1. NCT06059664. The EFfect of FinErenone in Kidney TransplantiOn Recipients: the EFFEKTOR study. https://clinicaltrials.gov/ct2/show/NCT06059664 2023.
NCT06114953 {published data only}
    1. NCT06114953. Comparative efficacy of mizoribine with mycophenolate mofetil for living related kidney transplantation recipients. https://clinicaltrials.gov/ct2/show/NCT06114953 2023.

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References to other published versions of this review

Christiadi  2019
    1. Christiadi D, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database of Systematic Reviews 2019, Issue 5. Art. No: CD013344. [DOI: 10.1002/14651858.CD013344] - DOI - PMC - PubMed

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