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

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ClinicalTrials.gov Identifier: NCT02474667
Recruitment Status : Active, not recruiting
First Posted : June 18, 2015
Last Update Posted : June 3, 2021
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Delayed Graft Function Drug: ANG-3777 Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

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 Name: Normal saline

Primary Outcome Measures :
  1. The severity of DGF [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474667

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Sponsors and Collaborators
Angion Biomedica Corp
CTI Clinical Trial and Consulting Services
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Study Director: John Neylan, MD Angion Biomedica
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Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT02474667    
Other Study ID Numbers: 001-15
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Angion Biomedica Corp:
Delayed Graft Function
Renal Transplantation
Deceased Donor Kidney
Kidney Transplantation
Acute Kidney Injury
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action