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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01387659
• Other study ID #: 10-244
• Status: Terminated
• Phase: N/A
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: September 2013
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Immunosuppression

Intervention

Procedure:
• Gastric emptying test
Gastric emptying tests will be performed at baseline, 6 months and 12 months

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	GI complications	Gastric emptying test	24 months
Secondary	Graft function	Renal function assessed by serum creatinine and calculating creatinine clearance.; Pancreas function assessed by glucose control, exogenous insulin requirement, HgbA1C	24 months
Secondary	Biopsy proven rejection	Renal graft core biopsy will be performed on all suspected rejection.	24 months