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NCT00149968 Clinical Trial

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

Renal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00149968
Other study ID # CERL080ADE05
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2005
Est. completion date January 2007

Study information
Verified date October 2009
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 196
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Bolin P, Tanriover B, Zibari GB, Lynn ML, Pirsch JD, Chan L, Cooper M, Langone AJ, Tomlanovich SJ. Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. Transplantation. 2007 Dec 15;84(11):1443-51. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in gastrointestinal symptom severity after conversion from MMF to enteric-coated mycophenolate sodium week 0, week 6-8
Secondary Gastrointestinal symptoms under MMF-based immunosuppressive therapy week 0, week 6-8
Secondary 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
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