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NCT03713645 · ClinicalTrials.gov registry record · Phase 4
Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients
A Phase 4 study of Kidney Transplant, sponsored by Temple University.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT03713645: Completed Phase 4 study of Kidney Transplant, sponsored by Temple University.
NCT03713645 is a Phase 4 study of Kidney Transplant that has completed, run by Temple University. The registered enrollment target is 36 participants, below the 1,897-participant average among 30 other Kidney Transplant trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03713645, a Phase 4 study of Kidney Transplant, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Outcomes after kidney transplantation have been significantly enhanced with the advances made in immunosuppressive therapies. Tacrolimus is currently marketed as an extended-release once-daily formulation dosing option for patients, decreasing pill burden and possibly decreasing adverse effects. Some transplant recipients have been shown to have higher dosage requirements. According to the literature, this can be linked to genetic disparities in the metabolism of tacrolimus.. This potential complication, where differences on specific genes alters metabolism of tacrolimus, can increase difficulty in getting to a therapeutic drug level for immunosuppresants and is one large factor that contributes to the fact that kidney transplant survival rates differ between patients. Due to the enhanced bioavailability of Meltdose formulation once-daily extended-release tacrolimus, its de novo use in recent research and practice has been shown to expedite achievement of target tacrolimus trough concentrations. De novo use of once-daily tacrolimus formulations is understudied. Through a prospective investigational study, we aim to determine the optimal strategy for de novo dosing of once-daily extended release tacrolimus (MeltDose formulation) for kidney transplant recipients at Temple University Hospital.
Primary Outcome
Therapeutic tacrolimus trough= 8-10ng/mL
Conditions Studied
Interventions
- DRUG Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant
Study Locations (1)
Pennsylvania
- Temple University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-11-12 |
| Est. Completion | 2022-01-31 |
| Phase | Phase 4 |
What the finished NCT03713645 record still lists
NCT03713645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,897-participant average among 30 other Kidney Transplant trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Kidney Transplant appearing as the primary indexed condition, and to 1 intervention - of which Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant is the first listed.
NCT03713645 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03713645 about?
NCT03713645 is a clinical study titled "Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients". Outcomes after kidney transplantation have been significantly enhanced with the advances made in immunosuppressive therapies. Tacrolimus is currently marketed as an extended-release once-daily formulation dosing option for patients, decreasing pill burden and possibly decreasing adverse effects. Som...
What is the current status of trial NCT03713645?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2018-11-12. Estimated completion is 2022-01-31.
What conditions does trial NCT03713645 study?
This clinical trial studies the following conditions: Kidney Transplant.
What interventions are being tested in trial NCT03713645?
The interventions under investigation include: Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant (DRUG).
Who is sponsoring clinical trial NCT03713645?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03713645 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03713645's enrollment target sits among peer trials
36 20th of 30 higher than 11 of 30 other Kidney Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant 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.
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