BridgeMD
Tests treatment safety and results for Ischemia Reperfusion Injury
Official title Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
ClinicalTrials.gov ID: NCT04005469
What this study is testing
What is Treprostinil?
Treprostinil is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischemia reperfusion injury.
Also referred to as Remodulin®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
- Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with...
You likely can't join if
- Under the age of 18 years
- Difficult venous access
- BMI \> 40 kg/m2
- Patients with severe clinical gastroparesis as determined by repeated vomiting
- Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
- Known or history of inflammatory bowel disease or bezoars
See the full eligibility criteria
- 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.
- Documentation of a diabetes diagnosis as evidenced by one or more clinical features consistent will be noted for all patients.
- 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.
- Under the age of 18 years
- Difficult venous access
- BMI \> 40 kg/m2
- Patients with severe clinical gastroparesis as determined by repeated vomiting
- Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
- Known or history of inflammatory bowel disease or bezoars
- History of diverticulitis, diverticular stricture, and other intestinal strictures
- Be receiving any investigational drug other than treprostinil or participating in any other investigational study
- Be receiving any prostanoid therapy to treat portopulmonary hypertension
- Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil
- Have had a failed kidney transplant within the previous 180 days
- Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results
- Those with significant cardiovascular disease including treatment with inotropes
- If female, be pregnant or nursing (confirmed by urine test)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.