A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients - Full Text View

Sponsors and Collaborators:	University of Pittsburgh Novartis
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00336817

Purpose

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.

Condition	Intervention
Immunosuppression	Drug: Myfortic Drug: CellCept

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Mycophenolic acid Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Incidence and severity of GI adverse events of Myfortic at 3 months [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
assessment of GI tolerability using a GI symptom rating scale 2 weeks, 6 weeks, and 3 months after initiation of the drug [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: No ]
incidence of biopsy-proven acute cellular rejection during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
incidence of graft loss or death during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
assessment of renal- and neurotoxic-sparing effects during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
assessment of neurotoxic-sparing effects during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence and severity of leukopenia during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
incidence of cytomegalovirus infection or disease during the study period [ Time Frame: 2, 6 and 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Myfortic 360mg or 720 mg BID for 90 days

CellCept 500mg or 1000mg BID for 90 days

Detailed Description:

This is a prospective, randomized, double-blinded, single center, safety and efficacy study comparing Myfortic with CellCept used after liver transplantation. Patients with biopsy-proven acute cellular rejection, renal insufficiency (i.e. acute or chronic renal failure requiring hemodialysis or patients with creatinine clearance < 50 ml/min), or calcineurin inhibitor-induced neurotoxicity (defined as the presence of neurologic symptoms such as tremors, altered mental status, seizures, etc) will be randomized to start on either Myfortic (720 mg po bid) or CellCept (1 gm po bid). In those patients with calcineurin-induced neurotoxicity or nephrotoxicity, tacrolimus or cyclosporine doses will also be reduced to maintain serum trough levels of 4-8 mg/dl or 100-200 mg/dl, respectively.

Comparison: Thirty patients will be enrolled and randomized in this two-armed, double-blinded study— half of the patients will receive Myfortic and the other half, CellCept.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336817

Contacts

Contact: Michael E de Vera, MD	412-647-5174	deverame@upmc.edu
Contact: Laurie K Hope, RN	412-692-2208	hopelk@upmc.edu

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Michael E de Vera, MD 412-647-5174 deverame@upmc.edu
Contact: Laurie K Hope, RN 412-692-2208 hopelk@upmc.edu
Principal Investigator: Michael E de Vera, MD
Sub-Investigator: J. Wallis Marsh, MD
Sub-Investigator: Paulo Fontes, MD
Sub-Investigator: Kyle Soltys, MD
Sub-Investigator: Roberto Lopez, MD
Sub-Investigator: Deanna Blisard, MD
Sub-Investigator: Vinay Kumaran, MD
Sub-Investigator: Igor Dvorchik, MD
Sub-Investigator: Raman Venkataramanan, MD
Sub-Investigator: Barbara Yelochan, RN

Sponsors and Collaborators

University of Pittsburgh

Novartis

Investigators

Principal Investigator:

Michael E de Vera, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	UPMC ( Michael de Vera, M.D. )
Study ID Numbers:	CERL080A-US26
Study First Received:	June 12, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00336817 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Liver transplantation
mycophenolate mofetil
gastrointestinal
adverse effects

Study placed in the following topic categories:

Anti-Bacterial Agents
Immunologic Factors
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mycophenolate mofetil

Mycophenolic Acid
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009