title: Long-term Follow-up of Kidney Transplant Recipients in the Spare-the-Nephron-Trial.
abstract: 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.
authors.affiliation: 1 School of Medicine, University of Maryland, Baltimore, MD. 2 Emory University, Atlanta, GA. 3 Henry Ford Hospital, Detroit, MI. 4 California Pacific Medical Center, San Francisco, CA. 5 University of Iowa, Iowa City, IA. 6 Stanford University, Palo Alto, CA. 7 University of Colorado, Denver, CO. 8 Medical University of South Carolina, Charleston, SC. 9 Baylor University Medical Center, Dallas, TX. 10 St. Barnabas Medical Center, Newark, NJ. 11 University of Kentucky, Lexington, KY. 12 Vanderbilt University Medical Center, Nashville, TN. 13 Our Lady of Lourdes Medical Center, Camden, NJ. 14 CTI Clinical Trial and Consulting Services, Cincinatti, OH.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Weir
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Pearson
authors.forename: Anita
authors.initials: A
authors.lastname: Patel
authors.forename: V Ram
authors.initials: VR
authors.lastname: Peddi
authors.forename: Roberto
authors.initials: R
authors.lastname: Kalil
authors.forename: John
authors.initials: J
authors.lastname: Scandling
authors.forename: Lawrence
authors.initials: L
authors.lastname: Chan
authors.forename: Prabhakar
authors.initials: P
authors.lastname: Baliga
authors.forename: Larry
authors.initials: L
authors.lastname: Melton
authors.forename: Shamkant
authors.initials: S
authors.lastname: Mulgaonkar
authors.forename: Thomas
authors.initials: T
authors.lastname: Waid
authors.forename: Heidi
authors.initials: H
authors.lastname: Schaefer
authors.forename: Nasser
authors.initials: N
authors.lastname: Youssef
authors.forename: Lali
authors.initials: L
authors.lastname: Anandagoda
authors.forename: David
authors.initials: D
authors.lastname: McCollum
authors.forename: Sibylle
authors.initials: S
authors.lastname: Lawson
authors.forename: Robert
authors.initials: R
authors.lastname: Gordon
mesh_terms: D000328:Adult; D065095:Calcineurin Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D057915:Drug Substitution; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016030:Kidney Transplantation / Q000009:adverse effects / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D009399:Nephrons / Q000187:drug effects* / Q000503:physiopathology; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus