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NCT03511560 · ClinicalTrials.gov registry record · Phase 4

Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation

A Phase 4 study, sponsored by Columbia University.

Completed
Registry status
Phase 4
Development phase
50
Enrollment target

NCT03511560 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 50 participants.

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The verdict

NCT03511560, a Phase 4 study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
Phase 4
Development phase
50 participants
Enrollment target

Study Summary

This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus XR) versus twice daily Tacrolimus (Prograf). It will examine kidney function between the two groups using estimated glomerular filtration rate (eGFR) and also examine one-year kidney outcomes, including graft loss and patient death. Patients will be followed for up to 1 year during the open-label study period.

Interventions

  • DRUG Tacrolimus
  • DRUG Tacrolimus Extended Release Oral Tablet

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2018-07-26
Est. Completion 2021-07-17
Phase Phase 4

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT03511560

The ClinicalTrials.gov registry entry for NCT03511560 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Tacrolimus is the first listed.

NCT03511560 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03511560 about?

NCT03511560 is a clinical study titled "Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation". This is a one year, prospective, randomized, open-label trial examining once versus twice daily tacrolimus dosing regimen using two preparations, extended-release Tacrolimus (Envarsus XR) versus twice daily Tacrolimus (Prograf). It will examine kidney function between the two groups using estimated ...

What is the current status of trial NCT03511560?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2018-07-26. Estimated completion is 2021-07-17.

What interventions are being tested in trial NCT03511560?

The interventions under investigation include: Tacrolimus (DRUG), Tacrolimus Extended Release Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT03511560?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

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

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.