Immunosuppression | A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
Immunosuppression research study
What is the primary objective of this study?
The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.
Who is eligible to participate?
Inclusion Criteria: - ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age. - Patients must be 30 to 180 days (1 to 6 months) post-transplant to be eligible. - Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen. - Patients with renal insufficiency (history of renal insufficiency or renal failure in the past, patients on hemodialysis, patients with a rising creatinine post-transplant). - Patients with biopsy-proven acute cellular rejection (mild, moderate, or severe based on Rejection Activity Index (RAI) as graded by pathologists at UPMC) or repeated bouts of rejection (greater than 2 episodes within a 30 day period). - Patients with tacrolimus- or cyclosporine-induced neurotoxicity. - Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period. Exclusion Criteria: - Multi-organ transplant patients. - HIV positive patients. - Living-related liver transplant recipients - Pregnant patients and nursing mothers. - Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin. - Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment. - Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus. - Evidence of drug and/or alcohol abuse. - Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:MyforticMyfortic 360mg or 720 mg BID for 90 days
Drug:CellCeptCellCept 500mg or 1000mg BID for 90 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Myfortic GroupSubjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days
CellCept GroupSubjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days
Start Date: November 2006
Completed Date: November 2008
Primary Outcome: GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil
Secondary Outcome: Drug Discontinuation Due to Side Effects
Study sponsors, principal investigator, and references
Principal Investigator: Michael E de Vera, MD
Lead Sponsor: University of Pittsburgh
Collaborator: Novartis Pharmaceuticals