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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149968
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : October 15, 2009
Information provided by:

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : April 2005
Primary Completion Date : January 2007
Study Completion Date : January 2007

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Gastrointestinal symptoms under MMF-based immunosuppressive therapy [ Time Frame: week 0, week 6-8 ]
  2. 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 ]

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149968

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

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
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by Novartis:
Renal transplantation
GI problems

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action