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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

Must not have

Receiving any prostanoid therapy to treat portopulmonary hypertension

Receiving any investigational drug other than treprostinil or participating in any other investigational study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 30

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on medication for portopulmonary hypertension.

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I am not taking any experimental drugs except for treprostinil.

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I frequently vomit due to severe gastroparesis.

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I have a history of diverticulitis or other types of bowel narrowing.

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I have had surgery on my digestive system, but it was not for gallbladder removal, appendix removal, or acid reflux correction.

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I have or had inflammatory bowel disease or bezoars.

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I have hard-to-find veins for IVs or blood draws.

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I am on a unique treatment plan that might interfere with the study.

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I have serious heart disease and need medication to help my heart pump.

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I am under 18 years old.

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I am not pregnant or nursing.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serum creatinine (SCr)

Secondary study objectives

Delayed graft function

INR

Primary graft non-function; kidney failure

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met