Clinical trial NCT01387659: Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Immunosuppression
Keywords: Myfortic
Simulect
Steroids
Diabetes
Transplant
Gastric emptying
Gastric motility
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-07-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.
2. Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated)
3. Written inform consent obtained. The patients are willing to participate in the study at UTMB.
4. Female with negative pregnancy test.
5. PRA \< 20 %.
6. En-blocks and two kidneys (tx'd at the same time) will be allowed.
7. Cold Ischemia time ≤ 30 hrs
8. Hep C patients will be allowed to enroll in this study

Exclusion Criteria:

1. Multi-organ transplants
2. Transplant from non-heart beating donor (NHBD) or dual transplants
3. A-B-O incompatible or positive cross match
4. Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications.
5. Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding
6. Inability to tolerate oral medications
7. Inability to sign a written consent form or to cooperate with investigators
8. Use of an investigational medication in the past 30 days.
9. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
10. HIV positive patients
11. History of psychosocial instability
12. Mental incompetence

Primary outcomes:
measure: Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids
timeFrame: 24 months
Secondary outcomes:
measure: GI complications
timeFrame: 24 months
measure: Graft function
timeFrame: 24 months
measure: Biopsy proven rejection
timeFrame: 24 months
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Luca Cicalese, MD
role: PRINCIPAL_INVESTIGATOR
References: