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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: September 6, 2005
Last updated: October 14, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Renal Transplantation Gastrointestinal Problems Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Renal Transplant Recipients (MyLife)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium [ Time Frame: week 0, week 6-8 ]

Secondary Outcome Measures:
  • Gastrointestinal symptoms under MMF-based immunosuppressive therapy [ Time Frame: 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 [ Time Frame: week 0, week 6-8 ]

Enrollment: 196
Study Start Date: April 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Myfortic Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Patient on MMF treatment completes questionnaire and switch to equimolar doses of Myfortic. Maximum daily dose 1440 mg
Other Name: Myfortic


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00149968

Bonn, Germany
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Novartis
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00149968     History of Changes
Other Study ID Numbers: CERL080ADE05
Study First Received: September 6, 2005
Last Updated: October 14, 2009

Keywords provided by Novartis:
Renal transplantation
GI problems

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on June 23, 2017