Exploratory Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation from Donors after Cardiac Death

Phase 1

• Conditions: Patients suffering from end-stage renal disease, receiving a donor kidney from donors after cardiac death; MedDRA version: 14.1Level: LLTClassification code 10014647Term: End stage renal failureSystem Organ Class: 100000004857

• Registration Number: EUCTR2010-019243-19-GB
• Lead Sponsor: Angion Biomedica Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-30
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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.
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 <10 mL/min., OR no urine output or < 50 cc/H over a 24 hour period, OR normal urine output following transplantation that diminished to < 50 cc/H over a 24 hour period OR Creatinine reduction ratio 24 hours after transplantation to pre-transplantation is < 30%.
8.Dry weight = 100 kg.
9.Women of child bearing potential have a negative pregnancy test prior to transplantation.
10.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.
11.In the opinion of the Investigator, the subject is capable of understanding and complying with the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

1.Mean arterial pressure <40 mmHg or cardiac index <1.8 L/min/m2.
2.Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
3.Recipient of kidney from a pediatric donor age 10 years or less.
4.Recipient age > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified