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

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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)

196 participants in 1 patient group

Myfortic
Experimental group
Treatment:
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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