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

NCT00267150 | Completed Phase 3 Results

• 1 other identifier: CERL080ADE10
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Transplantation; Kidney Transplantation

Keywords

Simultaneous Pancreas-Kidney Transplantation; mycophenolate; GI problems

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy

  week 0

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Enteric-coated mycophenolate sodium (EC-MPS) DRUG

Experimental

Also known as: myfortic

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Universitätsklinikum Charité Campus Virchow Klinikum Berlin Nephrologie und Internistische Intensivmedizin

Berlin, 13353, Germany

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2005
• First Posted: December 20, 2005
• Study Start: November 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 20, 2011
• Results First Posted: December 24, 2010

Record last verified: 2011-05

Locations

DE (1)