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NCT02723591 · ClinicalTrials.gov registry record · Phase 4

To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients

A Phase 4 study, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 4
Development phase
599
Enrollment target

NCT02723591 is a Phase 4 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 599 participants.

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The verdict

NCT02723591, a Phase 4 study, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 4
Development phase
599 participants
Enrollment target

Study Summary

This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first year post-transplant.

Interventions

  • DRUG Tacrolimus
  • DRUG Tacrolimus immediate release

Trial Details

FieldValue
Enrollment Target 599 participants
Start Date 2016-09-09
Est. Completion 2019-06-14
Phase Phase 4

Sponsor

Astellas Pharma Global Development

168 total trials

What the Registry Record Tells You About NCT02723591

The ClinicalTrials.gov registry entry for NCT02723591 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 599 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

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

NCT02723591 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02723591 about?

NCT02723591 is a clinical study titled "To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients". This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants maintained on twice daily, immediate-release tacrolimus versus those mai...

What is the current status of trial NCT02723591?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 599 participants. The study started on 2016-09-09. Estimated completion is 2019-06-14.

What interventions are being tested in trial NCT02723591?

The interventions under investigation include: Tacrolimus (DRUG), Tacrolimus immediate release (DRUG).

Who is sponsoring clinical trial NCT02723591?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

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.