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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: Completed Phase 4 study, sponsored by Astellas Pharma Global Development.
NCT02723591 is a Phase 4 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 599 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DSA was considered as a categorical (binary) variable with positivity determined at a threshold criteria approaching mean fluorescence intensity (MFI)=1000 at any time during the study. IA was considered either present or absent using the Trugraf™ v2.0 molecular assay. A negative designation (Trugraf TX Normal) was referred to as Immune Quiescence (IQ). Due to operating characteristics of the assay, a positive designation was considered evidence of IA in all participants.
Interventions
- DRUG Tacrolimus
- DRUG Tacrolimus immediate release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 599 participants |
| Start Date | 2016-09-09 |
| Est. Completion | 2019-06-14 |
| Phase | Phase 4 |
What the finished NCT02723591 record still lists
NCT02723591 is an interventional study that assigns participants to a tested intervention. The registered 599 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus is the first listed.
NCT02723591 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02723591's enrollment target sits among peer trials
599 147th of 2000 higher than 1,854 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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