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

This study has been terminated.
(Study terminated due to slow enrollment)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01387659
First received: June 8, 2011
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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, our study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients.


Condition Intervention Phase
Diabetes
Immunosuppression
Procedure: Gastric emptying test
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects


Secondary Outcome Measures:
  • GI complications [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Gastric emptying test

  • Graft function [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    Renal function assessed by serum creatinine and calculating creatinine clearance.

    Pancreas function assessed by glucose control, exogenous insulin requirement, HgbA1C


  • Biopsy proven rejection [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Renal graft core biopsy will be performed on all suspected rejection.


Enrollment: 2
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 emptying test
  • Gastric motility

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387659

Locations
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas, Galveston
Novartis Pharmaceuticals
Investigators
Principal Investigator: Luca Cicalese, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT01387659     History of Changes
Other Study ID Numbers: 10-244
Study First Received: June 8, 2011
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
Myfortic
Simulect
Steroids
Diabetes
Transplant
Gastric emptying
Gastric motility

ClinicalTrials.gov processed this record on September 16, 2014