Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants

Phase 3

Completed

• Conditions: Pancreas Transplantation; Kidney Transplantation
• Interventions: Drug: Enteric-coated mycophenolate sodium (EC-MPS)

• Registration Number: NCT00267150
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-16
• Study First Submitted QC: 2005-12-16
• Study First Posted: 2005-12-20
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2010-12-09
• Results First Submitted QC: 2010-12-09
• Results First Posted: 2010-12-24
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-17
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Enteric-coated mycophenolate sodium (EC-MPS)	-

Primary Outcome Measures

Name	Time	Method
Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium	weeks 6-8	The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy	week 0	Assessed by GI complications at baseline.

Trial Locations

Locations (1)

Universitätsklinikum Charité Campus Virchow Klinikum Berlin Nephrologie und Internistische Intensivmedizin; 🇩🇪 Berlin, Germany