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 Gaynor, David Roth, Junichiro Sageshima, Warren Kupin, Lissett Tueros, Lois Hanson, Anne Rosen, Phillip Ruiz, Joshua Miller

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

Fingerprint

Mycophenolic Acid
Tacrolimus
Kidney
Graft Survival
daclizumab
Transplant Recipients
thymoglobulin
Drug Monitoring
Incidence
Immunosuppressive Agents
Glomerular Filtration Rate
Creatinine
Diabetes Mellitus
Adrenal Cortex Hormones
Hospitalization
Steroids
Biopsy

Keywords

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

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

@article{c3681134a7194dd0b14265e9efe1d4d5,
title = "Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplant recipients given tacrolimus and daclizumab/thymoglobulin: One year follow-up",
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.",
keywords = "Acute rejection, Daclizumab, Mycophenolate, Myfortic, Renal allograft, Steroid avoidance, Tacrolimus, Thymoglobulin",
author = "Gaetano Ciancio and Burke, {George W} and Jeffrey Gaynor and David Roth and Junichiro Sageshima and Warren Kupin and Lissett Tueros and Lois Hanson and Anne Rosen and Phillip Ruiz and Joshua Miller",
year = "2008",
month = "7",
day = "15",
doi = "10.1097/TP.0b013e3181734b4a",
language = "English",
volume = "86",
pages = "67--74",
journal = "Transplantation",
issn = "0041-1337",
publisher = "Lippincott Williams and Wilkins",
number = "1",

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TY - JOUR

T1 - Randomized trial of mycophenolate mofetil versus enteric-coated mycophenolate sodium in primary renal transplant recipients given tacrolimus and daclizumab/thymoglobulin

T2 - One year follow-up

AU - Ciancio, Gaetano

AU - Burke, George W

AU - Gaynor, Jeffrey

AU - Roth, David

AU - Sageshima, Junichiro

AU - Kupin, Warren

AU - Tueros, Lissett

AU - Hanson, Lois

AU - Rosen, Anne

AU - Ruiz, Phillip

AU - Miller, Joshua

PY - 2008/7/15

Y1 - 2008/7/15

N2 - 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.

AB - 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.

KW - Acute rejection

KW - Daclizumab

KW - Mycophenolate

KW - Myfortic

KW - Renal allograft

KW - Steroid avoidance

KW - Tacrolimus

KW - Thymoglobulin

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U2 - 10.1097/TP.0b013e3181734b4a

DO - 10.1097/TP.0b013e3181734b4a

M3 - Article

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VL - 86

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JO - Transplantation

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