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

Kidney Transplantation Clinical Trial

Official title:

Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Simultaneous Pancreas-Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267150
• Other study ID #: CERL080ADE10
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2005
• Last updated: May 17, 2011
• Start date: November 2005
• Est. completion date: January 2008

Study information

• Verified date: May 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation
• Pancreas Transplantation

Intervention

Drug:
• Enteric-coated mycophenolate sodium (EC-MPS)
Experimental

Locations

Country	Name	City	State
Germany	Universitätsklinikum Charité Campus Virchow Klinikum Berlin Nephrologie und Internistische Intensivmedizin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium	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.	weeks 6-8	No
Secondary	Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy	Assessed by GI complications at baseline.	week 0	No