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NCT04005469 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
A Phase 1 study of Delayed Graft Function and Ischemia Reperfusion Injury, sponsored by Rhode Island Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04005469 is a Phase 1 study of Delayed Graft Function and Ischemia Reperfusion Injury that is actively recruiting participants, run by Rhode Island Hospital. The registered enrollment target is 20 participants, below the 371-participant average among 6 other Delayed Graft Function trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04005469, a Phase 1 study of Delayed Graft Function and Ischemia Reperfusion Injury, is actively recruiting participants, sponsored by Rhode Island Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate the restoration of blood supply to the revascularized kidney graft via its vasodilatory actions, well characterized protective effects, and longer elimination half-life. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.
Conditions Studied
Interventions
- DRUG Treprostinil
Study Locations (1)
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04005469
The ClinicalTrials.gov registry entry for NCT04005469 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 371-participant average among 6 other Delayed Graft Function trials with a reported enrollment target (95% lower). The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Delayed Graft Function appearing as the primary indexed condition, and to 1 intervention - of which Treprostinil is the first listed.
NCT04005469 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT04005469 about?
NCT04005469 is a clinical study titled "Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation". The objectives of this study are to test the preliminary safety and efficacy of a two-day peri-operative course of treprostinil in reducing ischemia-reperfusion injury in adult patients receiving a deceased donor kidney transplantation. Treprostinil, a prostacyclin analog, is expected to facilitate ...
What is the current status of trial NCT04005469?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-11-13. Estimated completion is 2026-06-30.
What conditions does trial NCT04005469 study?
This clinical trial studies the following conditions: Delayed Graft Function, Ischemia Reperfusion Injury.
What interventions are being tested in trial NCT04005469?
The interventions under investigation include: Treprostinil (DRUG).
Who is sponsoring clinical trial NCT04005469?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04005469 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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