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

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

Detailed Description
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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.

Official Title
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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

Conditions
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End Stage Renal Disease (ESRD)

Intervention / Treatment
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* Drug: Mycophenolic Acid (Myfortic)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mycophenolic Acid (Myfortic) Preload<br>Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter | Drug: Mycophenolic Acid (Myfortic)<br>* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).<br>* Other names: mycophenolic acid enteric coated;|
| Active Comparator: Mycophenolic Acid (Myfortic) Standard<br>Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day). | Drug: Mycophenolic Acid (Myfortic)<br>* Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).<br>* Other names: mycophenolic acid enteric coated;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of All Biopsy Proven Acute Rejection. | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Allograft Survival 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. | 12 months | 
| Renal Function at 12 Months | Renal function measured by serum creatinine (SCr) at 12 months post-transplant | 12 months | 
| Incidence of Post Transplant Infections | Incidence of post transplant infections that resulted in hospitalization | 12 months | 
| GI Toxicities | Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney, Transplant, Corticosteroid, Myfortic