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

Delayed Graft Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02474667
• Other study ID #: 001-15
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: September 2021

Study information

• Verified date: April 2021
• Source: Angion Biomedica Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 253
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Delayed Graft Function

Intervention

Drug:
• ANG-3777

Other:
• Placebo

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	University of Colorado Hospital Anschuts Medical Campus	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Montefiore Medical Center BRANY	Bronx	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Northwestern University	Evanston	Illinois
United States	Houston Methodist Hospital	Houston	Texas
United States	Kansas University	Lawrence	Kansas
United States	Keck Hospital of USC	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital in Arizona	Phoenix	Arizona
United States	Virginia Commonwealth University (VCU) Medical Center of Virginia	Richmond	Virginia
United States	UC Davis Medical Center	Sacramento	California
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
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 Washinton Medical Center	Seattle	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	Medstar Georgetown University Hospital	Washington	District of Columbia
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Angion Biomedica Corp	CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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