Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplant recipients given tacrolimus and daclizumab/thymoglobulin: One year follow-up

Gaetano Ciancio, George W. Burke, Jeffrey J. Gaynor, David Roth, Junichiro Sageshima, Warren Kupin, Lissett Tueros, Lois Hanson, Anne Rosen, Phillip Ruiz, Joshua Miller

Research output: Contribution to journalArticle

53 Scopus citations

Abstract

BACKGROUND.: It was of interest to compare enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) among renal transplant recipients receiving a tacrolimus-based immunosuppressive regimen. METHODS.: Between December 2004 and February 2006, a single-center, open-label randomized trial of MMF (group A, n=75) versus EC-MPS (group B, n=75) was performed in primary renal transplant recipients receiving combined thymoglobulin/daclizumab induction along with reduced tacrolimus dosing and elimination of corticosteroids 1 week postoperatively. The primary endpoint was the incidence rate of acute rejection (AR) during the first 12 months posttransplant; secondary aims were to compare graft and patient survival, renal function, drug dosing and monitoring, gastrointestinal side effects, and other adverse events at 12 months of follow-up. RESULTS.: Patient/graft survival in groups A and B were 100%/96% versus 99%/96%, respectively (N.S.). At 12 months, a total of nine patients (6%) experienced biopsy-proven AR, 3% (2/75) vs. 9% (7/75) in the MMF and EC-MPS arms, respectively (N.S.). At 12 months, the geometric mean*/SE serum creatinine concentration and arithmetic mean±SE calculated glomerular filtration rate in groups A and B, respectively, were 1.30*/1.03 and 61.4±2.0 vs. 1.26*/1.03 and 66.0±2.1 (N.S.). Incidence of new onset diabetes mellitus (11% vs. 11%), infections requiring hospitalization (13% vs. 15%), and gastrointestinal side effects (36% vs. 32%) appeared equivalent (N.S.). CONCLUSIONS.: Early efficacy and toxicity were equivalent between the two study arms. Optimizing either MMF or EC-MPS along with a combined thymoglobulin/daclizumab induction, low tacrolimus dosing and steroid avoidance resulted in a low AR rate and an acceptably high renal function at 12 months.

Original languageEnglish (US)
Pages (from-to)67-74
Number of pages8
JournalTransplantation
Volume86
Issue number1
DOIs
StatePublished - Jul 15 2008

Keywords

  • Acute rejection
  • Daclizumab
  • Mycophenolate
  • Myfortic
  • Renal allograft
  • Steroid avoidance
  • Tacrolimus
  • Thymoglobulin

ASJC Scopus subject areas

  • Transplantation
  • Immunology

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