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

University of Cincinnati

Status and phase

Completed

Phase 4

Conditions

End Stage Renal Disease (ESRD)

Treatments

Drug: Mycophenolic Acid (Myfortic)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00374803

MyforticINVINT

Details and patient eligibility

About

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

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 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.