Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (Formerly BB3) to Improve Graft Function and Reduce the Severity of Kidney Dysfunction or Delayed Graft Function Following Kidney Transplantation in Recipients of a Deceased Donor Kidney
1 other identifier
interventional
253
1 country
30
Brief Summary
The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
Longer than P75 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJune 3, 2021
April 1, 2021
5.5 years
June 12, 2015
June 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The severity of DGF
The primary endpoint is renal function assessed by eGFR (using the CKD-EPI equation based on serum creatinine), with a primary analysis time point consisting of eGFR at month 12.
Day 360
Study Arms (2)
BB3
ACTIVE COMPARATORAdministered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row
Normal Saline
PLACEBO COMPARATORAdministered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row
Interventions
Eligibility Criteria
You may qualify if:
- All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
- Males and females ≥ 18 years of age.
- Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
- Patient is to be the recipient of a first kidney transplant from a deceased donor.
- Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
- Body mass index \< 40 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used..
- Estimated donor organ cold ischemia time less than 30 hours (for PMP kidneys less than 40 hours).
You may not qualify if:
- Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
- Recipient of an ABO-incompatible kidney.
- Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
- Recipient of a kidney preserved by normothermic pulsatile machine perfusion.
- Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
- Currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. Patients cannot be given another investigational agent during the course of this study (through Day 360). Patients may participate in another concurrent study only if that study is a non-interventional, observational investigation.
- Concurrent sepsis or active bacterial infection.
- Has an active malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Angion Biomedica Corplead
- CTI Clinical Trial and Consulting Servicescollaborator
Study Sites (30)
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
California Institute of Renal Research
San Diego, California, 92123, United States
California Pacific Medical Center (Sutter)
San Francisco, California, 94115, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
University of Colorado Hospital Anschuts Medical Campus
Aurora, Colorado, 80045, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Rush University
Chicago, Illinois, 60612, United States
Northwestern University
Evanston, Illinois, 60208, United States
Kansas University
Lawrence, Kansas, 66045, United States
University of Louisville
Louisville, Kentucky, 40292, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center BRANY
The Bronx, New York, 10467, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45221, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22904, United States
Virginia Commonwealth University (VCU) Medical Center of Virginia
Richmond, Virginia, 23298, United States
University of Washinton Medical Center
Seattle, Washington, 98195, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Neylan, MD
Angion Biomedica
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 18, 2015
Study Start
March 1, 2016
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
June 3, 2021
Record last verified: 2021-04