Myfortic Conversion Trial in OLT Recipients With GI Intolerance - Full Text View

Sponsors and Collaborators:	The University of North Carolina, Chapel Hill Novartis Pharmaceuticals
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00619216

Purpose

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.

Condition	Intervention
GI Disturbance	Drug: Mycophenolic Acid (Myfortic)

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Tacrolimus Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Equimolar conversion from mycophenolate mofetil to mycophenolic acid

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619216

Contacts

Contact: Valorie Buchholz, RN

919-966-8227

buchholz@med.unc.edu

Locations

United States, North Carolina
University of North Carolina-Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599-7211

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

Novartis Pharmaceuticals

Investigators

Principal Investigator:

David Gerber, MD

UNC-Chapel Hill Department of Surgery

More Information

Responsible Party:	UNC Department of Surgery ( David Gerber, MD/Principal Investigator )
Study ID Numbers:	07-1203
Study First Received:	February 7, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00619216
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

Orthotopic Liver Transplant Recipients with GI disturbance

Study placed in the following topic categories:

Cyclosporine
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Cyclosporins

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009