Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Delayed Graft Function

In brief

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.

Key facts

Study ID

NCT02474667

Run by

Angion Biomedica Corp

People needed

253

Starts

2016-03-01

Expected to finish

2021-09-01

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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