Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Pop… (NCT01387659) | Clinical Trial Compass
TerminatedNot Applicable
Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
Stopped: Study terminated due to slow enrollment
United States2 participantsStarted 2011-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Multi-organ transplants
✕. Transplant from non-heart beating donor (NHBD) or dual transplants
✕
What they're measuring
1
Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids
Timeframe: 24 months
Trial details
NCT IDNCT01387659
SponsorThe University of Texas Medical Branch, Galveston