Campath, calcineurin inhibitor reduction, and chronic allograft nephropathy (the 3C Study) - results of a randomized controlled clinical trial.

3C Study Collaborative Group None.

Calcineurin inhibitors (CNIs, eg, tacrolimus) reduce short-term kidney transplant failure, but chronic nephrotoxicity may contribute to late transplant loss. Elective conversion to inhibitors of the mammalian target of rapamycin (mTOR, eg, sirolimus) pathway might avoid long-term CNI renal damage and improve outcomes. The 3C Study was a pragmatic randomized controlled trial of sequential randomizations between alemtuzumab and basiliximab induction therapy (at the time of surgery) and between tacrolimus and sirolimus maintenance therapy at 6 months posttransplantation. The primary outcome of this analysis was estimated glomerular filtration rate (eGFR) at 18 months after maintenance therapy randomization; 197 patients were assigned sirolimus-based and 197 to tacrolimus-based therapy. Allocation to sirolimus had no significant effect on eGFR at 18 months: baseline-adjusted mean (SEM) eGFR was 53.7 (0.9) mL/min/1.73 m2 in the sirolimus group versus 54.6 (0.9) mL/min/1.73 m2 in the tacrolimus group (P = .50). Biopsy-proven acute rejection (29 [14.7%]) vs 6 [3.0%]; P 

DOI

10.1111/ajt.14619

Type

Journal article

Journal

Am J Transplant

Publication Date

06/2018

Volume

18

Pages

1424 - 1434

Keywords

clinical research/practice, immunosuppressant - calcineurin inhibitor (CNI), immunosuppressant - fusion proteins and monoclonal antibodies: alemtuzumab, immunosuppressant - fusion proteins and monoclonal antibodies: basiliximab/daclizumab, immunosuppressant - mechanistic target of rapamycin (mTOR), immunosuppression/immune modulation, kidney transplantation/nephrology, Adult, Alemtuzumab, Calcineurin Inhibitors, Female, Glomerular Filtration Rate, Humans, Immunosuppressive Agents, Kidney Diseases, Male, Middle Aged, Transplantation, Homologous

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