Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
NCT ID: NCT02474667
Last Updated: 2021-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
253 participants
INTERVENTIONAL
2016-03-31
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BB3
Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row
ANG-3777
Normal Saline
Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row
Placebo
Interventions
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ANG-3777
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males and females ≥ 18 years of age.
3. Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
4. Patient is to be the recipient of a first kidney transplant from a deceased donor.
5. Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
6. Body mass index \< 40 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used..
7. Estimated donor organ cold ischemia time less than 30 hours (for PMP kidneys less than 40 hours).
Exclusion Criteria
2. Recipient of an ABO-incompatible kidney.
3. Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
4. Recipient of a kidney preserved by normothermic pulsatile machine perfusion.
5. Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
6. 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.
7. Concurrent sepsis or active bacterial infection.
8. 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.
18 Years
ALL
No
Sponsors
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CTI Clinical Trial and Consulting Services
OTHER
Angion Biomedica Corp
INDUSTRY
Responsible Party
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Principal Investigators
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John Neylan, MD
Role: STUDY_DIRECTOR
Angion Biomedica
Locations
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Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Keck Hospital of USC
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
California Institute of Renal Research
San Diego, California, United States
California Pacific Medical Center (Sutter)
San Francisco, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
University of Colorado Hospital Anschuts Medical Campus
Aurora, Colorado, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Rush University
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Kansas University
Lawrence, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center BRANY
The Bronx, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University (VCU) Medical Center of Virginia
Richmond, Virginia, United States
University of Washinton Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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001-15
Identifier Type: -
Identifier Source: org_study_id
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