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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 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.

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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.

Conditions Studied

End Stage Renal Disease

Interventions

  • DRUG Tacrolimus
  • DRUG Envarsus XR

Study Locations (1)

Kentucky

  • Deepa Valvi - Lexington

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2019-03-28
Est. Completion 2026-03-31
Phase Phase 2

Sponsor

Roberto Gedaly

2 total trials

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What the Registry Record Tells You About NCT03321656

The ClinicalTrials.gov registry entry for NCT03321656 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 833-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (91% lower). The listed sponsor is Roberto Gedaly, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.