Myfortic Conversion Trial in OLT Recipients With GI Intolerance

Completed

• Conditions: GI Disturbance

• Registration Number: NCT00619216
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-20
• Study Start: 2008-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-03

Recruitment & Eligibility

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

Inclusion Criteria

• Recipients of orthotopic liver transplant at least 8 weeks post transplant
• Mild and/or moderate GI complaints directly related to MMF

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Exclusion Criteria

• Multi-organ transplant recipients
• Evidence of graft rejection within 14 days prior to Baseline visit

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic	3 months

Trial Locations

Locations (1)

University of North Carolina-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States