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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delayed Graft Function
• Intervention / Treatment: Other: Placebo; Drug: ANG-3777

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital in Arizona
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • San Diego, California, United States, 92123
      • California Institute of Renal Research
    • San Francisco, California, United States, 94143
      • University of California San Francisco Medical Center
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center (Sutter)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital Anschuts Medical Campus
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Kansas
    • Lawrence, Kansas, United States, 66045
      • Kansas University
  • Kentucky
    • Louisville, Kentucky, United States, 40292
      • University Of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center BRANY
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University (VCU) Medical Center of Virginia
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washinton Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
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

1. Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BB3; Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row	Drug: ANG-3777; Other Names: Hepatocyte growth factor mimetic; BB3
Placebo Comparator: Normal Saline; Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row	Other: Placebo; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Angion Biomedica Corp
• Collaborators: CTI Clinical Trial and Consulting Services
• Investigators: Study Director: John Neylan, MD, Angion Biomedica

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Renal Transplantation; Kidney Transplantation; Acute Kidney Injury; Delayed Graft Function; DGF; Deceased Donor Kidney; BB3
• Additional Relevant MeSH Terms: Pathologic Processes; Death; Delayed Graft Function; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 001-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No