Myfortic Conversion Trial in OLT Recipients With GI Intolerance

NCT ID: NCT00619216

Last Updated: 2011-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-12-31

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.

Conditions

GI Disturbance

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Mycophenolic Acid (Myfortic)

Equimolar conversion from mycophenolate mofetil to mycophenolic acid

Intervention Type: DRUG

Other Intervention Names

Cellcept; Myfortic

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

UNC Department of Surgery

Principal Investigators

David Gerber, MD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill Department of Surgery

Locations

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

07-1203

Identifier Type: -

Identifier Source: org_study_id