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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


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 Months

Renal 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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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