Myfortic Conversion Trial in OLT Recipients With GI Intolerance

N/ACompletedNCT00619216

University of North Carolina, Chapel Hill31 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

GI Disturbance

Interventions

Mycophenolic Acid (Myfortic)DRUG

Equimolar conversion from mycophenolate mofetil to mycophenolic acid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Recipients of orthotopic liver transplant at least 8 weeks post transplant * Mild and/or moderate GI complaints directly related to MMF Exclusion Criteria: * Multi-organ transplant recipients * Evidence of graft rejection within 14 days prior to Baseline visit

Locations (1)

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic

Time frame: 3 months

Data from ClinicalTrials.gov

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