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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 : Recruiting
First Posted : June 18, 2015
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Angion Biomedica Corp

Brief Summary:

A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney.

The major objective is to demonstrate the safety and efficacy of ANG-3777 in 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: BB3 Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 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 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney
Study Start Date : January 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

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: BB3
Other Name: Hepatocyte growth factor mimetic

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: from the first day of study drug dosing (Day 1) until the last dialysis session or until Day 30, whichever comes first ]
    The severity of DGF will be assessed by its duration as measured by the number of days a patient remains dialysis dependent.



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

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


Contacts
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Contact: Gabrielle Pelle 516-326-1200 gpelle@angion.com

  Show 28 Study Locations
Sponsors and Collaborators
Angion Biomedica Corp
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: John Neylan, MD Angion Biomedica

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Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT02474667     History of Changes
Other Study ID Numbers: 001-15
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Keywords provided by Angion Biomedica Corp:
DGF
Delayed Graft Function
Renal Transplantation
Deseased Donor Kidney
BB3
Kidney Transplantation
Acute Kidney Injury
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes