Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/17531
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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
1534-6080
Statement of
Responsibility: 
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430 of 525 patients were eligible to be randomized to remain on triple-therapy (SRL-CsA-ST, n=215) or to have CsA withdrawn (SRL-ST, n=215).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: 10.1097/01.tp.0000178393.78084.9b
Appears in Collections:Medicine publications

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