Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
Stopped early · Not applicable
Conditions studied: Diabetes, Immunosuppression
In brief
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.
Key facts
- Study ID
- NCT01387659
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 2
- Starts
- 2011-03-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2020-11-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of Texas Medical Branch — Galveston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.