End-stage renal disease kidney transplantation nierfalen niertransplantatie
Conditions
Interventions
BB3 or placebo administration after kidney transplantation. 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 g
Sponsors
Angion Biomedica Europe LimitedAngion Biomedica Corp.1050 Stewart AvenueGarden City, NY 11530
Eligibility
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 fulfils the clinical site's criteria for transplantation; 7. Creatinine clearance from the transplanted kidney over a 2-hour collection period is <10 mL/min; 8. The contra lateral kidney will be transplanted at Maastricht University Medical Centre and its recipient is eligible to enroll and gives consent to participate in this trial (paired-kidney design). However if the second recipient of pair withdraws consent or no longer meets eligibility criteria after the first recipient has been enrolled, the first recipient will remain in the study; 9. Dry weight ≤ 100 kg; 10. Women of child bearing potential have a negative serum pregnancy test prior to transplantation; 11. Women of child bearing potential (including perimenopausal women who have had a menstrual period within 1 year) must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the 28-day study period. Men must agree to use condoms during the study period; A condom with spermicide is considered a single barrier; 12. In the opinion of the Investigator, the subject is capable of understanding and complying with the protocol.
Exclusion criteria
Exclusion criteria: 1. Mean arterial pressure 75 years; 6. Patients with ASA 4 or 5; 7. Patients with chronic obstructive pulmonary disease (COPD) GOLD IV; 8. Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy; 9. 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; 10. Subjects who are currently taking or within 2 weeks prior to Screening have taken medications for Parkinson's disease; 11. Subjects who are currently taking or within 2 weeks prior to Screening have taken medications for depression; 12. Repeated demonstration of QTc interval >450 ms for males and >470 ms for females on peri-operative and Screening ECGs; 13. Concurrent sepsis or active bacterial infection; 14. Have an active malignancy or history of solid, metastatic or haematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed; 15. Women of child bearing potential who is breast feeding; 16. History of positive HIV test; 17. History of rheumatoid arthritis; 18. History of proliferative retinopathy or laser surgery for retinopathy; 19. Subjects who have a penicillin allergy; 20. Subjects who require medications metabolized by CYP1A2 (see Chapter 5.2), or are receiving ciprofloxacin and fluvoxamine (Luvox®); 21. Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel; 22. 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 |
|---|---|
| The activity between BB3 and placebo on the following outcome measures will be compared: 1. Median time (days) until production of ≥1 litre urine over a 24-hour period, i.e. median number of days following the first infusion of study drug until the first day (08:00 - 08:00) that urine production was ≥1 litre over a 24-hour period; 2. Calculated creatinine clearance at days 14 and 28; 3. Incidence of delayed graft function (required dialysis due to inadequate renal function during the first 7 days after transplantation); 4. Number of dialysis sessions through day 7, 14, and 28; 5. Mean total daily urine output through day 14; 6. Daily serum creatinine at days 1 to 7 and at days 1 to 14; 7. Mean serum creatinine at days 4, 7, 10, 14, and 28; 8. Length of hospitalization following transplantation; 9. Results of the 6- and 12-month follow-up on graft survival and function will be summarized as an addendum to the final clinical study report. | — |
Contacts
Public ContactE.R.P. Hoogland
P.O. Box 5800
Outcome results
None listed