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

NCT01387659 | Terminated DMC

• 1 other identifier: 10-244
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Immunosuppression

Keywords

Myfortic; Simulect; Steroids; Diabetes; Transplant; Gastric emptying; Gastric motility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• GI complications

  24 months

• Graft function

  24 months

• Biopsy proven rejection

  24 months

Study Arms (1)

Transplant recipients

EXPERIMENTAL

All subjects receive identical drug treatment

Procedure: Gastric emptying test

Interventions

Gastric emptying test PROCEDURE

Gastric emptying tests will be performed at baseline, 6 months and 12 months

Also known as: Gastric motility

Transplant recipients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Luca Cicalese, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: July 4, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 17, 2020

Record last verified: 2013-09

Locations

US (1)