Myfortic Conversion Trial in OLT Recipients With GI Intolerance

University of North Carolina (UNC)

Status: Completed

Conditions: GI Disturbance

Treatments: Drug: Mycophenolic Acid (Myfortic)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00619216

07-1203

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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