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Cyclosporine withdrawal from a mycophenolate mofetil-containing immunosuppressive regimen in stable kidney transplant recipients: A randomized, controlled study

Lookup NU author(s): Professor Derek Manas


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Background. Long-term maintenance immunosuppression with cyclosporine (CsA) is associated with chronic transplant nephropathy and adverse effects on blood pressure and lipid profile. Several nonrandomized studies suggest that CsA might safely be withdrawn from immunosuppressive regimens containing mycophenolate mofetil (MMF; CellCept). Methods. A randomized, controlled study with 18.7 patients enrolled from 21 centers was conducted to compare CsA withdrawal with ongoing CsA therapy in stable renal transplant recipients receiving a triple-drug immunosuppressive regimen of MMF (2 g/day), CsA (Neoral), and corticosteroids. The primary end-point was creatinine clearance at 6 months after complete withdrawal. Results. In the intent-to-treat population, CsA withdrawal was associated with lower total cholesterol and low-density lipoprotein cholesterol (-0.3 mmol/L, P=0.02; -0.4 mmol/L, P=0.015). There was a trend toward improved creatinine clearance (4.5 mL/min, P=0.16) and serum creatinine (-1 vs. +4 mumol/L, P=0.34). In the per-protocol population, which excluded patients with acute rejections, the improvements in creatinine clearance and serum creatinine were statistically significant (7.5 mL/min, P=0.02; -11 vs. +4 mumol/L, P=0.0003). Reversible acute rejections, the majority of which were mild, occurred in nine CsA withdrawal versus two CsA continuation patients (10.6% vs. 2.4% of each group, P=0.03), with no graft loss. Conclusion. Withdrawal of CsA from an MMF-containing triple-drug immunosuppressive regimen improves renal function and lipid profile at the cost of a modest increase in acute rejections, without graft loss.

Publication metadata

Author(s): Abramowicz D, Manas D, Lao M, Vanrenterghem Y, del Castillo D, Wijngaard P, Fung S, Cyclosporine Withdrawal Study Grp

Publication type: Conference Proceedings (inc. Abstract)

Publication status: Published

Conference Name: Transplantation: 32nd Annual Meeting of the American Society of Nephrology

Year of Conference: 2002

Pages: 1725-1734

ISSN: 0041-1337

Publisher: Lippincott Williams & Wilkins


DOI: 10.1097/01.TP.0000038729.43731.F6

Library holdings: Search Newcastle University Library for this item

ISBN: 15346080