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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00267150
Recruitment Status : Completed
First Posted : December 20, 2005
Results First Posted : December 24, 2010
Last Update Posted : May 20, 2011
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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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: 1 Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Other Name: myfortic

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy [ Time Frame: week 0 ]
    Assessed by GI complications at baseline.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00267150

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

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00267150     History of Changes
Other Study ID Numbers: CERL080ADE10
First Posted: December 20, 2005    Key Record Dates
Results First Posted: December 24, 2010
Last Update Posted: May 20, 2011
Last Verified: May 2011

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

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents