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Type: Journal article
Title: Superior outcomes in renal transplantation after early cyclosporine withdrawal and sirolimus maintenance therapy, regardless of baseline renal function
Author: Russ, G.
Segoloni, G.
Oberbauer, R.
Legendre, C.
Mota, A.
Eris, J.
Grinyo, J.
Friend, P.
Lawen, J.
Hartmann, A.
Schena, F.
Lelong, M.
Burke, J.
Neylan, J.
Citation: Transplantation, 2005; 80(9):1204-1211
Publisher: Lippincott Williams & Wilkins
Issue Date: 2005
ISSN: 0041-1337
Statement of
Russ G, Segoloni G, Oberbauer R, Legendre C, Mota A, Eris J, Grinyó JM, Friend P, Lawen J, Hartmann A, Schena FP, Lelong M, Burke JT, Neylan JF; for the Rapamune Maintenance Regimen Study Group.
Abstract: It has become increasingly important to refine therapeutic strategies according to individual patient characteristics. We evaluated the long-term impact of renal function at the time of withdrawing cyclosporine (CsA) in renal allograft recipients receiving sirolimus (SRL), CsA, and steroids (ST). METHODS: At 3 months+/-2 weeks, 430 of 525 patients were eligible to be randomized to remain on triple-therapy (SRL-CsA-ST, n=215) or to have CsA withdrawn (SRL-ST, n=215). Patients were divided into quartiles according to their baseline (last value before randomization) calculated GFR: <or=45 ml/min (quartile 1, n=104), >45 to 56 ml/min (quartile 2, n=105), >56 to 67 ml/min (quartile 3, n=112), and >67 ml/min (quartile 4, n=107). All data were included (ITT analysis). RESULTS: At 4 years, calculated GFR for SRL-CsA-ST vs. SRL-ST was 22.1 vs. 37.7 ml/min (P=0.017), 38.6 vs. 56.6 ml/min (P<0.001), 50.7 vs. 66.8 ml/min (P=0.006), and 62.7 vs. 71.4 ml/min (P=0.436), for quartiles 1 to 4, respectively. Death-censored graft loss ranged from 21.2% vs. 7.7% (SRL-CsA-ST vs. SRL-ST, P=0.092) in quartile 1 to 5.5% vs. 1.9% (P=0.618) in quartile 4. The incidence of death and biopsy-confirmed acute rejection also decreased with increasing baseline GFR, but was not significantly different between treatments. Overall, more patients remained on therapy in the SRL-ST group (46.3% vs. 57.9%, P=0.020). CONCLUSIONS: Early and complete withdrawal of CsA from a combination of SRL, CsA, and steroids was preferable to continuing on this regimen, regardless of baseline renal function. The benefit was most marked in patients with a baseline calculated GFR<or=45 ml/min.
Keywords: Rapamune Maintenance Regimen Study Group; Kidney; Humans; Acute Disease; Sirolimus; Cyclosporine; Steroids; Immunosuppressive Agents; Glomerular Filtration Rate; Treatment Outcome; Drug Therapy, Combination; Kidney Transplantation; Drug Administration Schedule; Incidence; Graft Rejection; Adolescent; Adult; Aged; Middle Aged; Female; Male
RMID: 0020051823
DOI: 10.1097/
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