Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplant recipients given tacrolimus and daclizumab/thymoglobulin: one year follow-up.
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.
Ciancio
Gaetano
G
The Lillian Jean Kaplan Renal Transplant Center of the Division of Transplantation, Department of Surgery, University of Miami Miller School of Medicine, Miami, FL, USA. gciancio@med.miami.edu
Burke
George W
GW
Gaynor
Jeffrey J
JJ
Roth
David
D
Sageshima
Junichiro
J
Kupin
Warren
W
Tueros
Lissett
L
Hanson
Lois
L
Rosen
Anne
A
Ruiz
Phillip
P
Miller
Joshua
J
D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum; D000077561:Daclizumab; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013608:Tablets, Enteric-Coated; D016559:Tacrolimus / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000961:Antilymphocyte Serum; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D013608:Tablets, Enteric-Coated; D000077561:Daclizumab; C512542:thymoglobulin; D009173:Mycophenolic Acid; D016559:Tacrolimus