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Prostacyclin Analog

Treprostinil for Ischemia-Reperfusion Injury During Kidney Transplantation

Phase 1 & 2

Recruiting

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female patients aged 18 to 65 receiving a deceased donor kidney and on the active transplant list at RIH

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30

Awards & highlights

Study Summary

This trial tests if a drug called treprostinil can help reduce complications in adult kidney transplant recipients. 20 patients will receive it before and after surgery. Safety and efficacy are primary goals.

Who is the study for?

Adults aged 18-65 eligible for a deceased donor kidney transplant can join this trial. They must be on the RIH transplant list, able to follow study requirements, and have documented diabetes. Exclusions include inflammatory bowel disease, treprostinil hypersensitivity, recent failed kidney transplant, pregnancy or nursing women, extreme obesity (BMI > 40), certain GI surgeries or conditions, other drug trials participation, specific heart diseases.Check my eligibility

What is being tested?

The trial is testing Treprostinil's safety and effectiveness in reducing injury from blood supply restoration during kidney transplants. Participants will receive an IV infusion of Treprostinil before and for two days after surgery to see if it helps protect the new kidney.See study design

What are the potential side effects?

Potential side effects of Treprostinil may include issues related to its vasodilation properties such as headaches or flushing. It might also cause gastrointestinal discomfort due to its prostacyclin nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old, waiting for a kidney transplant from a deceased donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum creatinine (SCr)

Secondary outcome measures

Delayed graft function

INR

Primary graft non-function; kidney failure

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TrepostinilExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treprostinil

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,987 Total Patients Enrolled

University of Rhode IslandOTHER

52 Previous Clinical Trials

22,171 Total Patients Enrolled

United TherapeuticsIndustry Sponsor

107 Previous Clinical Trials

13,367 Total Patients Enrolled

Media Library

Treprostinil (Prostacyclin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04005469 — Phase 1 & 2

Delayed Graft Function Research Study Groups: Trepostinil

Delayed Graft Function Clinical Trial 2023: Treprostinil Highlights & Side Effects. Trial Name: NCT04005469 — Phase 1 & 2

Treprostinil (Prostacyclin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04005469 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common indications for Trepostinil consumption?

"Trepostinil has been identified as an effective means of treating pulmonary arterial hypertension, NYHA functional class III and IV."

Answered by AI

How many respondents have volunteered for this experiment?

"Correct. The available information on clinicaltrials.gov demonstrates that this medical experiment is still accepting registrations, which began being accepted on November 13th 2020 and were last updated July 18th 2023. A total of 20 participants are needed from a single site for this study to be completed."

Answered by AI

Are enrollments still open for this experimental research?

"Affirmative, clinicaltrials.gov data indicates that this trial is still recruiting participants who were initially posted on the 13th of November 2020 and revised most recently on 18 July 2023. This research requires approximately twenty volunteers from a single medical centre."

Answered by AI

Is the age restriction of this trial limited to persons over 20 years old?

"Patients who hope to join this medical trial must be of legal age and under the age of 65."

Answered by AI

Has Trepostinil been evaluated in any other research efforts?

"Currently, there are 8 clinical trials for Trepostinil being conducted. Two of those active studies have progressed to Phase 3. Though most research is taking place in Norfolk, Virginia, 147 sites around the world are assessing this medication's efficacy and safety."

Answered by AI

Is it possible for me to take part in this trial?

"This scientific trial is looking for 20 participants aged 18 to 65 who have delayed graft function. Furthermore, the involved patients must be male or female with diabetes and receive a deceased donor kidney from RIH, possess valid written consent (or assent) indicating their understanding of the study’s requirements and demonstrate an aptitude for compliance."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Reginald Gohh 2020. "Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04005469.

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