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NCT02866682 · ClinicalTrials.gov registry record · Phase 4
Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients
A Phase 4 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 176
- Enrollment target
NCT02866682 is a Phase 4 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 176 participants.
The verdict
NCT02866682, a Phase 4 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 176 participants
- Enrollment target
Study Summary
As the patents for brand-name immunosuppressive medications expire, there is increasing interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies showing bioequivalence, questions remain regarding the clinical impact of use of generic immunosuppression. The most important immunosuppressive agent in the modern transplant era is arguably tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to answer the question regarding the clinical impact of generic tacrolimus use as measured primarily by acute rejection, loss of graft function, and patient death through a randomized trial of 2 phases: Brand tacrolimus only, and Generic A tacrolimus only. Given that kidney transplantations are the most commonly performed transplants with well-defined measures of rejection and graft failure, this organs will be studied in a six-center study designed to accrue the target number of transplant recipients within the one-year study period. The study has now been branched off into 2 phases. Phase 1: consists of randomization of patients onto brand and generic tacrolimus. This was completed once 40 brand patients were enrolled. Phase 2: consists of patients being enrolled only on generic tacrolimus (standard of care from subject's insurance). This will be completed once there is a total of 160 generic participants. 200 participants total in the study.
Interventions
- DRUG Tacrolimus
- DRUG Prograf
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2021-06-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02866682
The ClinicalTrials.gov registry entry for NCT02866682 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus is the first listed.
NCT02866682 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02866682 about?
NCT02866682 is a clinical study titled "Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients". As the patents for brand-name immunosuppressive medications expire, there is increasing interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies showing bioequivalence, questions remain regarding the clinical impact of use of generic immunosuppression. The most im...
What is the current status of trial NCT02866682?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 176 participants. The study started on 2018-03-01. Estimated completion is 2021-06-11.
What interventions are being tested in trial NCT02866682?
The interventions under investigation include: Tacrolimus (DRUG), Prograf (DRUG).
Who is sponsoring clinical trial NCT02866682?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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