Status:
COMPLETED
Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Novartis
Conditions:
End Stage Renal Disease (ESRD)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
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 pharmaco...
Eligibility Criteria
Inclusion
- 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
- Patient previously received or is receiving an organ transplant other than kidney.
- Primary or re-transplant from human leukocyte antigen (HLA)-identical living donor.
- Recipient or donor is known to be seropositive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (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, mycophenolate mofetil (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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00374803
Start Date
April 1 2006
End Date
January 1 2008
Last Update
April 28 2016
Active Locations (2)
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1
The Christ Hospital
Cincinnati, Ohio, United States, 45267
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267