Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Mycophenolate sodium

• Registration Number: NCT00646737
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to evaluate the safety and the tolerability of the substitution of mycophenolate mofetil for enteric-coated mycophenolate sodium in a population of stable renal transplant patients in Brazil, in a treatment regimen of immunosuppressants with tacrolimus and mycophenolate mofetil.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Study Start: 2008-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Mycophenolate sodium	Mycophenolate sodium

Primary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms in renal transplant patients treated with the immunosuppression regimen of tacrolimus and mycophenolate at baseline, 8 and 16 weeks	8 and 16 weeks

Secondary Outcome Measures

Name	Time	Method
Impact of gastrointestinal symptoms on quality of life. Tolerability of mycophenolate sodium in combination with tacrolimus assessed by OSRS. Safety of mycophenolate sodium in combination with tacrolimus assessed by incidence of adverse events	8 and 16 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇧🇷 Sao Paulo, Brazil