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

Phase 4

Completed

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 pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Mycophenolic Acid (Myfortic) Preload	Mycophenolic Acid (Myfortic)	Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
Mycophenolic Acid (Myfortic) Standard	Mycophenolic Acid (Myfortic)	Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).

Primary Outcome Measures

Name	Time	Method
Incidence of All Biopsy Proven Acute Rejection.	12 months	Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine

Secondary Outcome Measures

Name	Time	Method
Patient and Allograft Survival 12 Months	12 months	Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival.
GI Toxicities	12 months	Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic)
Renal Function at 12 Months	12 months	Renal function measured by serum creatinine (SCr) at 12 months post-transplant
Incidence of Post Transplant Infections	12 months	Incidence of post transplant infections that resulted in hospitalization