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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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