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Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil

NCT00400647 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2017-02-07

No results posted yet for this study

Summary

This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS).

Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.

Conditions

  • Maintenance Kidney Transplant

Interventions

DRUG

Enteric-coated Mycophenolate sodium (EC-MPS)

DRUG

Mycophenolate mofetil

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Switzerland

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 NCT00400647 on ClinicalTrials.gov