Gastrointestinal and Health-Related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Information source: Novartis
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas Transplantation; Kidney Transplantation
Intervention: Enteric-coated mycophenolate sodium (EC-MPS) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis
Overall contact:
Novartis, Phone: 41 61 324 1111
Summary
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in
gastrointestinal (GI) complications in some patients. This study will assess if a switch from
MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or
health-related quality of life outcomes and determine the proportion of pancreas-kidney
transplant recipients who experience any GI complaints under MMF-based immunosuppressive
treatment.
Clinical Details
Official title: Measurement of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Simultaneous Pancreas-Kidney Transplant Recipients
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Changes in gastrointestinal symptom severity and/or health-related quality of life after conversion from MMF to enteric coated mycophenolate sodium
Secondary outcome: Gastrointestinal symptoms under MMF-based immunosuppressive therapy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Received simultaneous pancreas-kidney (SPK) transplant at least 3 months prior to
study enrollment
- Receiving immunosuppressive regimen that includes MMF in combination with other
immunosuppressive drugs (i. e., a calcineurin inhibitor, a mTOR inhibitor, steroids at
least for three months at time of study enrollment)
- Receiving MMF for at least 1 month prior to enrollment; maximal MMF dose 2000 mg/d.
Exclusion Criteria:
- Patients with any known hypersensitivity to mycophenolic acid, mycophenolate sodium,
mycophenolate mofetil or other components of the formulations (e. g. lactose; see also
SCP of EC-MPS)
- If applicable, GI symptoms assumed or known to be induced by other drugs or infections
(e. g. oral biphosphonates induced, infectious diarrhea)
- Acute rejection < 1 month prior to study enrollment
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis, Phone: 41 61 324 1111
Universitätsklinikum Charité Campus Virchow Klinikum Berlin Nephrologie und Internistische Intensivmedizin, Berlin 13353, Germany; Recruiting
Universitätsklinikum Charité Campus, Phone: 49 30 4505 53243
Additional Information
Starting date: November 2005
Ending date: February 2008
Last updated: June 3, 2008
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