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Myfortic Conversion Trial in OLT Recipients With GI Intolerance

NCT00619216 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2011-06-03

No results posted yet for this study

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.

Conditions

  • GI Disturbance

Interventions

DRUG

Mycophenolic Acid (Myfortic)

Equimolar conversion from mycophenolate mofetil to mycophenolic acid

Sponsors & Collaborators

Principal Investigators

  • David Gerber, MD · UNC-Chapel Hill Department of Surgery

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00619216 on ClinicalTrials.gov