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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01387659
Recruitment Status : Terminated (Study terminated due to slow enrollment)
First Posted : July 4, 2011
Last Update Posted : October 1, 2013
Novartis Pharmaceuticals
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease Intervention/treatment Phase
Diabetes Immunosuppression Procedure: Gastric emptying test Phase 4

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  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

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 Name: Gastric motility

Primary Outcome Measures :
  1. Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids [ Time Frame: 24 months ]
    Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects

Secondary Outcome Measures :
  1. GI complications [ Time Frame: 24 months ]
    Gastric emptying test

  2. Graft function [ Time Frame: 24 months ]

    Renal function assessed by serum creatinine and calculating creatinine clearance.

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

  3. Biopsy proven rejection [ Time Frame: 24 months ]
    Renal graft core biopsy will be performed on all suspected rejection.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01387659

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

Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT01387659     History of Changes
Other Study ID Numbers: 10-244
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by The University of Texas Medical Branch, Galveston:
Gastric emptying
Gastric motility

Additional relevant MeSH terms:
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents