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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00336817
First received: June 12, 2006
Last updated: October 2, 2008
Last verified: October 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients

Resource links provided by NLM:


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:
    Drug: Myfortic
    Myfortic 360mg or 720 mg BID for 90 days
    Drug: CellCept
    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: Michael de Vera, M.D., UPMC
ClinicalTrials.gov Identifier: NCT00336817     History of Changes
Other Study ID Numbers: CERL080A-US26
Study First Received: June 12, 2006
Last Updated: October 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Liver transplantation
mycophenolate mofetil
gastrointestinal
adverse effects

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014