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 36 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 75 years. 5. Patients with ASA 4 or 5 6. Patients with chronic obstructive pulmonary disease (COPD) GOLD IV 7. Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy. 8. Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrolment into this study. 9. Concurrent sepsis or active bacterial infection. 10. 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. 11. Women of child bearing potential who is breast feeding. 12. History of positive HIV test. 13. History of rheumatoid arthritis. 14. History of proliferative retinopathy or laser surgery for retinopathy. 15. Subjects who have a penicillin allergy. 16. Subjects who require the cytochrome P450 1A2 (CYP1A2) inhibitors, 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Pharmacokinetics Incidence of delayed graft function Mean urine output number of acute rejections hospitalstay | — |
Countries
Netherlands
Outcome results
None listed