Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 13, 2020

Primary Completion Date

July 1, 2025

Study Completion Date

June 30, 2026

Conditions
Ischemia Reperfusion InjuryDelayed Graft Function
Interventions
DRUG

Treprostinil

Treprostinil (Remodulin) will be administered IV by a standard 3 + 3 dose-escalation approach. This dosing model will be followed until a target dose of 15 mg/kg/min is achieved or if it is medically determined that side effects prevent dose escalation. IV infusion will commence approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of surgery, unless hemodynamic changes or tolerability require discontinuation of treprostinil.

Trial Locations (1)

02903

RECRUITING

Rhode Island Hospital, Providence

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Rhode Island

OTHER

collaborator

United Therapeutics

INDUSTRY

lead

Rhode Island Hospital

OTHER