Delayed Graft Function Clinical Trial
Official title:
A Phase I/II Study Evaluating the Preliminary Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During De Novo Adult Kidney Transplantation
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. These properties and actions of treprostinil make it a strong drug candidate to reduce kidney graft dysfunction during kidney transplantation. An anticipated 20 participants undergoing deceased donor kidney transplant will be hospitalized and intensively monitored during an entire two-day Treatment Phase. An IV infusion using a dedicated central venous line will be used to administer treprostinil commencing approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of the transplant surgery. The primary endpoints include the safety and efficacy of treprostinil, with secondary endpoints including the evaluation of both biochemical and clinical endpoints post-transplantation.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2026 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Rhode Island Hospital | United Therapeutics, University of Rhode Island |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum creatinine (SCr) | Primary efficacy assessment will include the cGFR using SCr during the first seven days post transplantation. | Day 1-7 | |
Secondary | INR | biochemical end point | Day 7 | |
Secondary | Urine output | biochemical end point | Day 7 | |
Secondary | Primary graft non-function; kidney failure | dialysis, death or re-transplantation | Day 30 | |
Secondary | Delayed graft function | use of dialysis | Day 30 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02312115 -
Delayed Renal Allograft Function and Furosemide Treatment
|
Phase 2 | |
Completed |
NCT02134314 -
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
|
Phase 1/Phase 2 | |
Completed |
NCT02346968 -
Evaluation of CAF22 After Renal Transplantation
|
||
Completed |
NCT01794663 -
Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function
|
Phase 2 | |
Completed |
NCT00298181 -
YSPSL for Prevention of Delayed Graft Function Part A
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05166460 -
Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
|
N/A | |
Recruiting |
NCT03071536 -
Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation
|
N/A | |
Not yet recruiting |
NCT05513807 -
Graft Acute Kidney Injury: Vitamin B3 to Facilitate Renal Recovery In the Early Life of a Transplant
|
Phase 3 | |
Completed |
NCT01848249 -
Deceased Donor Biomarkers and Recipient Outcomes
|
||
Active, not recruiting |
NCT02474667 -
Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
|
Phase 3 | |
No longer available |
NCT02026934 -
CliniMACS® CD34+ Reagent System for Expanded Access Use
|
N/A | |
Terminated |
NCT00217152 -
A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors
|
Phase 4 | |
Recruiting |
NCT05430620 -
Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys
|
Phase 3 | |
Completed |
NCT03864926 -
Envarsus in Delayed Graft Function (E-DGF)
|
Phase 4 | |
Recruiting |
NCT06367205 -
Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations
|
N/A | |
Completed |
NCT02610296 -
QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
|
Phase 3 | |
Active, not recruiting |
NCT02568696 -
Intra-graft Coagulation Events in Clinical Renal Transplantation and Delayed Graft Function
|
||
Recruiting |
NCT01837043 -
Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function
|
Phase 2 | |
Terminated |
NCT01878786 -
A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT01395719 -
Context - Remote Ischemic Conditioning in Renal Transplantation - Effect on Immediate and Extended Kidney Graft Function
|
N/A |