Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Jan-Feb;27(1):28-36.
doi: 10.4103/0971-4065.176146.

Efficacy and safety of early tacrolimus conversion to sirolimus after kidney transplantation: Long-term results of a prospective randomized study

A E El-Agroudy  1 , S M Alarrayed  2 , S M Al-Ghareeb  2 , E Farid  2 , H Alhelow  2 , S Abdulla  3
Affiliations

Efficacy and safety of early tacrolimus conversion to sirolimus after kidney transplantation: Long-term results of a prospective randomized study

A E El-Agroudy et al. Indian J Nephrol. 2017 Jan-Feb.

Abstract

We report a prospective, open-label, randomized study to evaluate the safety and efficacy of converting patients with a stable renal function from tacrolimus (Tac)-based regimen to a sirolimus (SRL)-based regimen after kidney transplantation. Fifty-eight low-risk renal allograft recipients who receiving Tac 6 months posttransplant, were randomly assigned to continue Tac (n = 29) or convert to SRL (n = 29). We evaluated the 3-year outcomes including patient and graft survival, graft function, and safety profile. Three-year patient and graft survival in SRL and Tac groups were 93.1% versus 100% (P = 0.32), and 89.7% versus 100% (P = 0.11), respectively. However, the SRL group had a significantly better renal function, from the 2nd year posttransplant until the last follow-up. Four (13.8%) patients in the SRL group and 3 (10.3%) in the Tac group (P = 0.5) developed biopsy-proven acute rejection. Mean urinary protein excretion increased significantly after SRL conversion. Diastolic blood pressure was significantly lower at the end of the study in patients who eliminated Tac (80.4 vs. 75.6 mmHg in Tac and SRL group, respectively) (P = 0.03). Mean hemoglobin concentrations decreased after SRL conversion and remained significantly lower from 12 months to 36 months (P = 0.01). The mean serum cholesterol (540 ± 44 mg/dl) and triglyceride (177 ± 27 mg/dl) increased significantly in the SRL group, compared to Tac group (487 ± 62 mg/dl) (P = 0.03) and (141 ± 26 mg/dl) (P = 0.04). Our experience demonstrates that conversion to SRL from calcineurin inhibitors-based therapy may result in better renal function and blood pressure control in renal transplant recipients without an increased risk of acute rejection. However, these benefits have not resulted in a growing advantage in graft or patient survival.

Keywords: Kidney transplant; outcome; sirolimus.

PubMed Disclaimer

Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Study flow diagram. The diagram illustrates the study enrollment and disposition of the trial participants
Figure 2
Figure 2
Kaplan–Meier graft survival curve in both groups
Figure 3
Figure 3
Kaplan–Meier patient survival curve in both groups
See this image and copyright information in PMC

References

    1. Solez K, Vincenti F, Filo RS. Histopathologic findings from 2-year protocol biopsies from a U.S. multicenter kidney transplant trial comparing tarolimus versus cyclosporine: A report of the FK506 Kidney Transplant Study Group. Transplantation. 1998;66:1736–40. - PubMed
    1. Meier-Kriesche HU, Li S, Gruessner RW, Fung JJ, Bustami RT, Barr ML, et al. Immunosuppression: Evolution in practice and trends, 1994-2004. Am J Transplant. 2006;6(5 Pt 2):1111–31. - PubMed
    1. Shihab FS. Cyclosporine nephropathy: Pathophysiology and clinical impact. Semin Nephrol. 1996;16:536–47. - PubMed
    1. Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med. 2004;351:2715–29. - PubMed
    1. Woolfson RG, Neild GH. Cyclosporin nephrotoxicity following cardiac transplantation. Nephrol Dial Transplant. 1997;12:2054–6. - PubMed