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. 2022 Apr 21;12(4):e048122.
doi: 10.1136/bmjopen-2020-048122.

Study protocol: the TRAnsplant BIOpsies (TRABIO) study - a prospective, observational, multicentre cohort study to assess the treatment of kidney graft rejections

Friedrich Alexander von Samson-Himmelstjerna #  1 , Grit Esser #  2 , Kevin Schulte  2 , Benedikt Kolbrink  2 , Markus Krautter  3 , Vedat Schwenger  3 , Julia Weinmann-Menke  4 , Julia Matschkal  5 , Florian Schraml  5 , Anne Pahl  5 , Matthias Braunisch  5 , Kerstin Amann  6 , Thorsten Feldkamp  2 , Ulrich Kunzendorf  2 , Lutz Renders  5 , Uwe Heemann  5 ; TRABIO Study Group
Affiliations

Study protocol: the TRAnsplant BIOpsies (TRABIO) study - a prospective, observational, multicentre cohort study to assess the treatment of kidney graft rejections

Friedrich Alexander von Samson-Himmelstjerna et al. BMJ Open. .

Abstract

Introduction: Despite continued efforts, long-term outcomes of kidney transplantation remain unsatisfactory. Kidney graft rejections are independent risk factors for graft failure. At the participating centres of the TRAnsplant BIOpsies study group, a common therapeutic standard has previously been defined for the treatment of graft rejections. The outcomes of this strategy will be assessed in a prospective, observational cohort study.

Methods and analysis: A total of 800 kidney transplantation patients will be enrolled who undergo a graft biopsy because of deteriorating kidney function. Patients will be stratified according to the Banff classification, and the influence of the treatment strategy on end points will be assessed using regression analysis. Primary end points will be all-cause mortality and graft survival. Secondary end points will be worsening of kidney function (≥30% decline of estimated Glomerular Filtration Rate [eGFR] or new-onset large proteinuria), recurrence of graft rejection and treatment response. Baseline data and detailed histopathology data will be entered into an electronic database on enrolment. During a first follow-up period (within 14 days) and subsequent yearly follow-ups (for 5 years), treatment strategies and clinical course will be recorded. Recruitment at the four participating centres started in September 2016. As of August 2020, 495 patients have been included.

Ethics and dissemination: Ethical approval for the study has been obtained from the ethics committee of Kiel (AZ B 278/16) and was confirmed by the committees of Munich, Mainz and Stuttgart. The results will be reported in a peer-reviewed journal, according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria.

Trial registration number: ISRCTN78772632; Pre-results.

Keywords: Nephrology; Renal transplantation; TRANSPLANT MEDICINE; Transplant pathology.

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Conflict of interest statement

Competing interests: JW-M has received research support from GSK, DIAMED, Miltenyi Biotech as well as personal fees from Novartis, GSK, Boehringer-Ingelheim, Miltenyi, Vifor and Chiesi (all unrelated to the submitted work).

Figures

Figure 1
Figure 1
Inclusion and exclusion criteria for enrolment of kidney transplant patients with suspected graft rejections.
Figure 2
Figure 2
Standard operating procedures for the treatment of kidney graft rejections, as applied by the participating centres. AMR, antibody-mediated rejection; BW, body wt; HUS, haemolytic uraemic syndrome; IFTA, interstitial fibrosis and tubular atrophy; IS, immunosuppression; MMF, mycophenolate mofetil acid; rATG, rabbit anti-thymocyte globulins; TCMR, T cell-mediated rejection.
Figure 3
Figure 3
A total of 800 patients who undergo indication biopsy for suspected kidney graft rejection at one of four German transplantation centres will be included in the study after obtaining their written informed consent. Data will be collected and recorded at enrolment and then at yearly follow-ups for 5 years.
Figure 4
Figure 4
Categories of data that will be recorded at enrolment and during follow-up visits. AB0, blood types A/B/0; DSA, donor-specific antibodies; IS, immunosuppression
See this image and copyright information in PMC

References

    1. Tonelli M, Wiebe N, Knoll G, et al. . Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant 2011;11:2093–109. 10.1111/j.1600-6143.2011.03686.x - DOI - PubMed
    1. Durrbach A, Francois H, Beaudreuil S, et al. . Advances in immunosuppression for renal transplantation. Nat Rev Nephrol 2010;6:160–7. 10.1038/nrneph.2009.233 - DOI - PubMed
    1. Ponticelli C, Tarantino A, Vegeto A. Renal transplantation, past, present and future. J Nephrol 1999;12 Suppl 2:S105–10. - PubMed
    1. Kramer A, Boenink R, Noordzij M, et al. . The ERA-EDTA registry annual report 2017: a summary. Clin Kidney J 2020;13:693–709. 10.1093/ckj/sfaa048 - DOI - PMC - PubMed
    1. Stel VS, Kramer A, Zoccali C, et al. . The 2006 ERA-EDTA registry annual report: a précis. J Nephrol 2009;22:1–12. - PubMed

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