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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: Recruiting Phase 1 study of Delayed Graft Function and Ischemia Reperfusion Injury, sponsored by Rhode Island Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary efficacy assessment will include the cGFR using SCr during the first seven days 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 |
What NCT04005469 shows while recruiting
NCT04005469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 371-participant average among 6 other Delayed Graft Function trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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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