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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00267150
First received: December 16, 2005
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Pancreas Transplantation
Kidney Transplantation
Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Simultaneous Pancreas-Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium [ Time Frame: weeks 6-8 ] [ Designated as safety issue: No ]
    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:
  • Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Assessed by GI complications at baseline.


Enrollment: 31
Study Start Date: November 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Experimental
Other Name: myfortic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267150

Locations
Germany
Universitätsklinikum Charité Campus Virchow Klinikum Berlin Nephrologie und Internistische Intensivmedizin
Berlin, Germany, 13353
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00267150     History of Changes
Other Study ID Numbers: CERL080ADE10
Study First Received: December 16, 2005
Results First Received: December 9, 2010
Last Updated: May 17, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Simultaneous Pancreas-Kidney Transplantation
mycophenolate
GI problems

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014