Myfortic Conversion Trial in OLT Recipients With GI Intolerance

Completed

Conditions studied: GI Disturbance

In brief

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.

Key facts

Study ID

NCT00619216

Run by

University of North Carolina, Chapel Hill

People needed

31

Starts

2008-03-01

Expected to finish

2009-12-01

Last updated by the study team

2011-06-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• University of North Carolina-Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.