Study of Myfortic in Combination With Tacrolimus and Thymoglobulin in Early Corticosteroid Withdrawal

Completed · Phase 4

Conditions studied: End Stage Renal Disease (ESRD)

In brief

To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.

Key facts

Study ID

NCT00374803

Run by

University of Cincinnati

People needed

45

Starts

2006-04-01

Expected to finish

2008-01-01

Last updated by the study team

2016-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Christ Hospital — Cincinnati, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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