Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
- Registration Number
- NCT02474667
- Lead Sponsor
- Angion Biomedica Corp
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 253
- 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).
Exclusion Criteria
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Saline Placebo Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row BB3 ANG-3777 Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row
- Primary Outcome Measures
Name Time Method The severity of DGF Day 360 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Washinton Medical Center
🇺🇸Seattle, Washington, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Kansas University
🇺🇸Lawrence, Kansas, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
Rush University
🇺🇸Chicago, Illinois, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Montefiore Medical Center BRANY
🇺🇸Bronx, New York, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Hospital in Arizona
🇺🇸Phoenix, Arizona, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
California Pacific Medical Center (Sutter)
🇺🇸San Francisco, California, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Colorado Hospital Anschuts Medical Campus
🇺🇸Aurora, Colorado, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Virginia Commonwealth University (VCU) Medical Center of Virginia
🇺🇸Richmond, Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States