Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations

Study Overview
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Brief Summary
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This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant recipient population, the study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients.

Detailed Description
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Myfortic® is an enteric-coated formulation of the sodium salt derivative of mycophenolic acid (MPA) that is administered to control kidney graft rejection. Myfortic® was developed to improve MPA-related upper gastrointestinal (GI) side effects by delaying the release of MPA until it reaches the large surface of the small bowel. Approximately half of all the kidney transplant recipients in the United States have diabetes mellitus. A recent analysis of approximately 30,000 kidney transplant recipients included in the U.S. Renal Data System showed that 42% of patients had pre-transplant diabetes (1). Moreover, 15% to 20% of patients develop diabetes after transplantation, a condition that is commonly known as post-diabetes mellitus (1-3). It was previously shown that the rate and extent of MPA absorption is minimally affected by diabetes (4). Limited data is available in the current literature on Myfortic® and Simulect® based therapy in diabetic patients.

Official Title
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Study to Evaluate Tolerability of Myfortic With Simulect Induction and Tacrolimus Without Steroids in Three Patient Populations; 1: Kidney/Pancreas Transplants,2: Diabetic Kidney Transplants, and 3: Non-diabetic Kidney Transplants

Conditions
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Diabetes, Immunosuppression

Intervention / Treatment
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* Procedure: Gastric emptying test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian. Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated) Written inform consent obtained. The patients are willing to participate in the study at UTMB. Female with negative pregnancy test. PRA < 20 %. En-blocks and two kidneys (tx'd at the same time) will be allowed. Cold Ischemia time ≤ 30 hrs Hep C patients will be allowed to enroll in this study Exclusion Criteria: Multi-organ transplants Transplant from non-heart beating donor (NHBD) or dual transplants A-B-O incompatible or positive cross match Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications. Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding Inability to tolerate oral medications Inability to sign a written consent form or to cooperate with investigators Use of an investigational medication in the past 30 days. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required) HIV positive patients History of psychosocial instability Mental incompetence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transplant recipients<br>All subjects receive identical drug treatment | Procedure: Gastric emptying test<br>* Gastric emptying tests will be performed at baseline, 6 months and 12 months<br>* Other names: Gastric motility;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids | Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI complications | Gastric emptying test | 24 months | 
| Graft function | Renal function assessed by serum creatinine and calculating creatinine clearance. Pancreas function assessed by glucose control, exogenous insulin requirement, HgbA1C | 24 months | 
| Biopsy proven rejection | Renal graft core biopsy will be performed on all suspected rejection. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myfortic, Simulect, Steroids, Diabetes, Transplant, Gastric emptying, Gastric motility