MedTrace Logo

Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance

NCT00400400 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2011-08-15

Study results available
· View outcomes & findings →

Summary

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

Conditions

  • Renal Transplantation

Interventions

DRUG

Placebo to mycophenolate sodium

Placebo to mycophenolate sodium matching tablets.

DRUG

Enteric-coated mycophenolate sodium (EC-MPS)

Enteric-coated mycophenolate sodium supplied as 180 mg tablets.

DRUG

Mycophenolate mofetil

Mycophenolate mofetil supplied as 250 mg capsules.

DRUG

Placebo to mycophenolate mofetil

Placebo to mycophenolate mofetil matching capsules.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00400400 on ClinicalTrials.gov