Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease (ESRD)
Intervention: Mycophenolic Acid (Myfortic) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s): Rita Alloway, PharmD, Principal Investigator, Affiliation: University of Cincinnati
Summary
To determine the safety and efficacy of a new formulation of Myfortic in combination with
tacrolimus and thymoglobulin.
Clinical Details
Official title: A 12-month, Prospective, Randomized, Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of All Biopsy Proven Acute Rejection.
Secondary outcome: Patient and Graft Survival at 12 MonthsRenal Function at 12 Months Incidence of PTDM, Post Transplant Infections Pharmacokinetic and Pharmacodynamic Profile
Detailed description:
Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and
anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective
is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid
withdrawal protocol.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females between 18 and 75 years of age.
- Patients who are primary or repeat cadaveric, living unrelated or non-HLA identical
living related donor renal transplant recipients.
Exclusion Criteria:
- Patient previously received or is receiving an organ transplant other than kidney.
- Primary or re-transplant from HLA-identical living donor.
- Recipient or donor is known to be seropositive for HCV, HBV, or HIV.
- Uncontrolled concomitant infection or other unstable medical condition.
- Patients that received an investigational drug in the 30 days prior to transplant.
- Known hypersensitivity to tacrolimus, MMF, enteric-coated mycophenolic acid, rabbit
anti-thymocyte globulin, or corticosteroids.
- Receiving chronic steroid therapy at the time of transplant.
- History of malignancy in last 5 years.
- Pregnant or lactating.
Locations and Contacts
The Christ Hospital, Cincinnati, Ohio 45267, United States
University of Cincinnati, Cincinnati, Ohio 45267, United States
Additional Information
Starting date: April 2006
Last updated: April 10, 2012
|