Could a 2-Day infusion save transplanted kidneys from early damage?
NCT ID NCT04005469
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called treprostinil can help prevent injury to a new kidney during transplant surgery. About 20 adults receiving a deceased donor kidney will get the drug through an IV for two days, starting just before surgery. The goal is to see if it improves blood flow and reduces the need for dialysis after transplant.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female patients who will receive a deceased donor kidney aged 18 to 65 (inclusive) and are currently on the active transplant list at RIH. 2. Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients. 3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: 1. Under the age of 18 years 2. Difficult venous access 3. BMI \> 40 kg/m2 4. Patients with severe clinical gastroparesis as determined by repeated vomiting 5. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication 6. Known or history of inflammatory bowel disease or bezoars 7. History of diverticulitis, diverticular stricture, and other intestinal strictures 8. Be receiving any investigational drug other than treprostinil or participating in any other investigational study 9. Be receiving any prostanoid therapy to treat portopulmonary hypertension 10. Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil 11. Have had a failed kidney transplant within the previous 180 days 12. Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results 13. Those with significant cardiovascular disease including treatment with inotropes 14. If female, be pregnant or nursing (confirmed by urine test) 15. Presence of a condition or abnormality that in the opinion of the Investigators that would compromise the safety of the patient or the quality of the data
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rhode Island Hospital
RECRUITINGProvidence, Rhode Island, 02903, United States
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Other studies related to the condition(s) this trial covers.
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- 30,000 dialysis patients tracked to map what works
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