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)
Verified date | October 2009 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Novartis | Basel |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Germany, Switzerland,
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
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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