Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)

Phase 4

Completed

• Conditions: Renal Transplantation; Gastrointestinal Problems
• Interventions: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

• Registration Number: NCT00149968
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to assess whether a switch from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2009-10
• Last Update Submitted: 2020-02-08
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Received kidney transplant at least 3 months prior to study enrollment
• Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs
• Receiving MMF for at least 1 month prior to enrollment

Exclusion Criteria

• Patients with any known hypersensitivity against mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also summary of product characteristics of EC-MPS)
• If applicable, GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates induced, infectious diarrhea)
• Acute rejection < 1 week prior to study enrollment

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myfortic	Enteric-Coated Mycophenolate Sodium (EC-MPS)	-

Primary Outcome Measures

Name	Time	Method
Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium	week 0, week 6-8

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptoms under MMF-based immunosuppressive therapy	week 0, week 6-8
Assessment of quality of life, impact of immunosuppressive-induced gastrointestinal symptoms on patient's perception of symptom severity and quality of life	week 0, week 6-8

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland