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NCT04225988 · ClinicalTrials.gov registry record · Phase 4

Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

A Phase 4 study of Kidney Transplant Rejection, sponsored by Cedars-Sinai Medical Center.

Completed
Registry status
Phase 4
Development phase
20
Enrollment target
1
Study location

NCT04225988 is a Phase 4 study of Kidney Transplant Rejection that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 20 participants, below the 803-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04225988, a Phase 4 study of Kidney Transplant Rejection, has completed, sponsored by Cedars-Sinai Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

This is a randomized, open-label, controlled clinical trial designed to compare clinical outcomes after kidney transplantation using extended-release tacrolimus (Envarsus XR) versus immediate tacrolimus among highly-sensitized kidney transplant recipients. Outcomes to be assessed include the incidence of biopsy-proven acute rejection at 12 months, the presence of de novo and pre-existing donor-specific HLA antibodies, estimated glomerular filtration rate, and the level of donor-derived cell-free DNA.

Conditions Studied

Kidney Transplant Rejection

Interventions

  • DRUG Extended-release tacrolimus
  • DRUG Immediate-release tacrolimus

Study Locations (1)

California

  • Cedars-Sinai Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2020-01-09
Est. Completion 2023-07-11
Phase Phase 4

Sponsor

Cedars-Sinai Medical Center

339 total trials

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What the Registry Record Tells You About NCT04225988

The ClinicalTrials.gov registry entry for NCT04225988 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 803-participant average among 8 other Kidney Transplant Rejection trials with a reported enrollment target (98% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Kidney Transplant Rejection appearing as the primary indexed condition, and to 2 interventions - of which Extended-release tacrolimus is the first listed.

NCT04225988 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT04225988 about?

NCT04225988 is a clinical study titled "Comparison of Tacrolimus Extended-Release (Envarsus XR) to Tacrolimus Immediate-Release in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients". This is a randomized, open-label, controlled clinical trial designed to compare clinical outcomes after kidney transplantation using extended-release tacrolimus (Envarsus XR) versus immediate tacrolimus among highly-sensitized kidney transplant recipients. Outcomes to be assessed include the inciden...

What is the current status of trial NCT04225988?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-01-09. Estimated completion is 2023-07-11.

What conditions does trial NCT04225988 study?

This clinical trial studies the following conditions: Kidney Transplant Rejection.

What interventions are being tested in trial NCT04225988?

The interventions under investigation include: Extended-release tacrolimus (DRUG), Immediate-release tacrolimus (DRUG).

Who is sponsoring clinical trial NCT04225988?

This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04225988 being conducted?

This trial has 1 study location across California. 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.