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

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes; Immunosuppression
• Intervention / Treatment: Procedure: Gastric emptying test

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Novartis Pharmaceuticals
• Investigators: Principal Investigator: Luca Cicalese, MD, University of Texas

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Diabetes; Transplant; Gastric emptying; Steroids; Simulect; Myfortic; Gastric motility
• Other Study ID Numbers: 10-244