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NCT03321656 · ClinicalTrials.gov registry record · Phase 2
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
A Phase 2 study of End Stage Renal Disease, sponsored by Roberto Gedaly.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT03321656: Recruiting Phase 2 study of End Stage Renal Disease, sponsored by Roberto Gedaly.
NCT03321656 is a Phase 2 study of End Stage Renal Disease that is actively recruiting participants, run by Roberto Gedaly. The registered enrollment target is 78 participants, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03321656, a Phase 2 study of End Stage Renal Disease, is actively recruiting participants, sponsored by Roberto Gedaly.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
We will check these donor specific antibodies to: HLA-A, -B and -C; or HLA-DR, -DQ and -DP. We will quantify the expression of these markers by Flow Cytometry analysis and reported as mean fluorescence intensity (MFI) units.
Conditions Studied
Interventions
- DRUG Tacrolimus
- DRUG Envarsus XR
Study Locations (1)
Kentucky
- Deepa Valvi - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
What NCT03321656 shows while recruiting
NCT03321656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (91% lower).
The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 2 interventions - of which Tacrolimus is the first listed.
NCT03321656 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT03321656 about?
NCT03321656 is a clinical study titled "Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile". 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.
What is the current status of trial NCT03321656?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2019-03-28. Estimated completion is 2026-03-31.
What conditions does trial NCT03321656 study?
This clinical trial studies the following conditions: End Stage Renal Disease.
What interventions are being tested in trial NCT03321656?
The interventions under investigation include: Tacrolimus (DRUG), Envarsus XR (DRUG).
Who is sponsoring clinical trial NCT03321656?
This trial is sponsored by Roberto Gedaly, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03321656 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for End Stage Renal Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03321656's enrollment target sits among peer trials
78 41st of 86 higher than 46 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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