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

Novartis

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Problems; Renal Transplantation

Treatments: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00149968

CERL080ADE05

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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196 participants in 1 patient group

Myfortic

Experimental group

Treatment:

Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)