Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Recruiting
Phase 2
Phase 3
Interventional Study
End Stage Renal Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 78 (estimated)
- Sponsor
- Roberto Gedaly · Other
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About This Trial
This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Fluent in English able to understand and provide informed consent.
* End stage renal disease listed for primary solitary kidney transplant.
* Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.
* Female w…
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