Long-term Follow-up of Kidney Transplant Recipients in the Spare-the-Nephron-Trial.
Weir MR, Pearson TC, Patel A, Peddi VR, Kalil R, Scandling J, Chan L, Baliga P, Melton L, Mulgaonkar S, Waid T, Schaefer H, Youssef N, Anandagoda L, McCollum D, Lawson S, and Gordon R. Long-term follow-up of kidney transplant recipients in the spare-the-nephron-trial. Transplantation 2016; 101(1):157-165.
In the Spare-the-Nephron (STN) Study, kidney transplant recipients randomized about 115 days posttransplant to convert from CNI (calcineurin inhibitor)/MMF to sirolimus (SRL)/MMF had a significantly greater improvement in measured GFR (mGFR) at 12 months compared with those kept on CNI/MMF. The difference at 24 months was not statistically significant. From 14 top enrolling centers, 128 of 175 patients identified with a functioning graft at 2 years consented to enroll in an observational, noninterventional extension study to collect retrospectively and prospectively annual follow-up data for the interval since baseline (completion of the parent STN study at 24 months posttransplant). Overall, 11 patients died, including 5 (7.6%) in the SRL/MMF group and 6 (9.7%) in the CNI/MMF group. Twenty-two grafts have been lost including 10 (15.2%) in the SRL/MMF arm and 12 (19.4%) in the CNI/MMF arm. Death and chronic rejection were the most common causes of graft loss in both arms. There were modestly more cardiovascular events in the MMF/SRL group. Estimated creatinine clearance (Cockcroft-Gault) from baseline out to 6 additional years (8 years posttransplant, ITT analysis, SRL/MMF, n = 34; CNI/MMF, n = 26) was 63.2 ± 28.5 mL/min/1.73 m in the SRL/MMF group and 59.2 ± 27.2 mL/min/1.73 m in the CNI/MMF group and was not statistically significant, but there is a clinically meaningful trend for improved long-term renal function in the SRL/MMF group compared with the CNI/MMF group. The long-term decision for immunosuppression needs to be carefully individualized.
Medical Subject Headings
Adult; Calcineurin Inhibitors; Cyclosporine; Drug Substitution; Drug Therapy, Combination; Female; Follow-Up Studies; Glomerular Filtration Rate; Graft Rejection; Graft Survival; Humans; Immunosuppressive Agents; Kidney Transplantation; Male; Middle Aged; Mycophenolic Acid; Nephrons; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies; Sirolimus; Tacrolimus; Time Factors; Treatment Outcome; United States