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Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients

NCT00522548 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2018-01-23

Study results available
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Summary

Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients. However, enteric coated mycophenolate sodium has been thought to possibly be associated with fewer gastrointestinal side effects. Mycophenolate mofetil and enteric coated mycophenolate sodium pharmacokinetics (how the drug is absorbed and broken down) have not been well-studied in African American kidney transplant recipients. The investigators are interested in studying enteric coated mycophenolate sodium and mycophenolate mofetil pharmacokinetics and gastrointestinal side effects in African American kidney transplant recipients.

Conditions

  • Transplants and Implants

Interventions

DRUG

Enteric coated mycophenolate sodium

Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.

DRUG

Mycophenolate mofetil

Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent formulation manufactured by Sandoz, in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.

Sponsors & Collaborators

Principal Investigators

  • Roy Bloom, MD · University of Pennsylvania-Renal Electrolyte and Hypertension Division

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-01-31
Completion
2011-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522548 on ClinicalTrials.gov