Delayed graft function
Conditions
Interventions
One group receives 4 intravenous infusions of 2 mg/kg BB3 at 6-9, 24±3, 48±3
and 72±3 hours following kidney transplantation and the other group receives an
equal volume of normal saline at the same
Sponsors
Angion Biomedica Corp.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must sign the informed consent document prior to performance of any study related procedure including the screening procedure. 2. Males and females * 18 years of age. 3. Had renal transplantation due to end stage disease requiring chronic dialysis. 4. Study drug can be administered within 6 to 9 hours after transplantation. 5. Received kidney from donor after cardiac death. 6. DCD kidney fulfills the clinical site*s criteria for transplantation. 7. Creatinine clearance from the transplanted kidney over a 2-hour collection period is
Exclusion criteria
Exclusion criteria: 1. Mean arterial pressure 450 ms for males and >470 ms for females on peri-operative and screening ECGs 10. Concurrent sepsis or active bacterial infection 11. Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed 12. Women of child bearing potential who is breast feeding 13. History of positive HIV test 14. History of rheumatoid arthritis 15. History of proliferative retinopathy or laser surgery for retinopathy 16. Subjects who require medications metabolized by CYP1A2, or are receiving ciprofloxacin and fluvoxamine (Luvox®) 17. Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel 18. Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject*s primary nephrologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary analysis to assess the activity of BB3 compared to placebo will be the mean difference in creatinine clearance over time using selective 24-hour urine collections from the transplanted kidney from the first infusion of study drug through day 7 post-transplant. If a subject has more than one creatinine value assessed during the 24-hour urine collection, the mean of the values will be used for calculation of creatinine clearance. | — |
Countries
Netherlands
Outcome results
None listed