BB3 in Kidney Transplantation.
- Conditions
- End-stage renal diseasekidney transplantationnierfalenniertransplantatie
- Registration Number
- NL-OMON22050
- Lead Sponsor
- Angion Biomedica Europe LimitedAngion Biomedica Corp.1050 Stewart AvenueGarden City, NY 11530
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
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;
Exclusion Criteria
1. Mean arterial pressure <40 mmHg or cardiac index <1.8 L/min/m2;
2. Requires emergency dialysis for reasons other than high plasma creatinine levels, e.g. severe fluid overload or severe metabolic abnormalities;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method