Actively Recruiting
A Phase I/II Study Evaluating the Preliminary Safety and Efficacy of Treprostinil (Remodulin ae) In Reducing Ischemia-Reperfusion Injury During De Novo Adult Kidney Transplantation
Led by Rhode Island Hospital · Updated on 2026-04-23
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rhode Island Hospital
Lead Sponsor
U
University of Rhode Island
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary safety and effectiveness of treprostinil, a prostacyclin analog, in reducing ischemia-reperfusion injury in adults receiving a deceased donor kidney transplant. This study focuses on kidney transplant patients aged 18 to 65 and aims to assess whether treprostinil can help restore blood flow to the new kidney and reduce graft dysfunction after transplantation. Treprostinil will be given through an intravenous infusion starting about 2 to 3 hours before the kidney transplant surgery and continuing for approximately 48 hours after surgery. The dose is gradually increased until reaching a target dose or until side effects require stopping the medication. Participants will be hospitalized and closely monitored during this two-day treatment phase. Participants will undergo intensive monitoring including blood tests to measure serum creatinine from day 1 to 7, along with other assessments such as INR, urine output, and evaluation for kidney function outcomes up to 30 days post-transplant. Safety and tolerability will also be observed throughout the treatment period. The total participation duration includes hospitalization for the treatment phase and follow-up assessments as specified in the study timeline.
CONDITIONS
Brief Title
Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 to 65 years who will receive a deceased donor kidney and are on the active transplant list at Rhode Island Hospital
- Documentation of a diabetes diagnosis as evidenced by one or more clinical features
- Ability to provide written informed consent and comply with study requirements
You will not qualify if you...
- Under 18 years of age
- Difficult venous access
- Body mass index (BMI) over 40 kg/m2
- Severe clinical gastroparesis with repeated vomiting
- Prior gastrointestinal surgery except cholecystectomy, appendectomy, or Nissen fundoplication
- Known or history of inflammatory bowel disease or bezoars
- History of diverticulitis, diverticular stricture, or other intestinal strictures
- Receiving any investigational drug other than treprostinil or participating in another investigational study
- Receiving prostanoid therapy for portopulmonary hypertension
- Known hypersensitivity to prostaglandins, prostacyclin, or treprostinil
- Had a failed kidney transplant within the previous 180 days
- Receiving any non-standard immunosuppression or treatment affecting study results
- Significant cardiovascular disease including treatment with inotropes
- Pregnant or nursing females
- Any condition or abnormality that may compromise safety or data quality as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 days
Participants receive Treprostinil by IV infusion starting approximately 2-3 hours before kidney transplantation surgery and continuing for about 48 hours after surgery, unless side effects require stopping the medication.
1 hospitalization period including infusion and surgery
Duration - Up to 30 days after surgery
Participants are monitored for kidney function and recovery, including assessments of serum creatinine, urine output, and graft function.
Multiple visits during first 30 days post-transplant
Trial Site Locations
Total: 1 location
1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
G
George Bayliss, MD
N
Nisanne Ghonem, PharmD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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