A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms

NCT00658333 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-08-07

Study results available
· View outcomes & findings →

Summary

To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms

Conditions

  • Renal Transplantation

Interventions

DRUG

Enteric-coated Mycophenolate Acid (EC-MPA)

DRUG

Mycophenolate Mofetil (MMF)

DRUG

Placebo MMF

DRUG

Placebo EC-MPA

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00658333 on ClinicalTrials.gov