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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: Completed Phase 4 study, sponsored by Columbia University.
NCT03511560 is a Phase 4 study that has completed, run by Columbia University. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tacrolimus metabolism was determined for all dates of tacrolimus blood trough concentration collection after renal transplantation by dividing the tacrolimus blood trough concentration (C) by the corresponding total daily tacrolimus dose (D). C/D ratio (ng/mL\*1/mg) = blood tacrolimus trough level (ng/mL)/total daily tacrolimus dose (mg).
Interventions
- DRUG Tacrolimus
- DRUG Tacrolimus Extended Release Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-07-26 |
| Est. Completion | 2021-07-17 |
| Phase | Phase 4 |
What the finished NCT03511560 record still lists
NCT03511560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus is the first listed.
NCT03511560 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03511560's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 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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