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

This study is currently recruiting participants.
Verified August 2017 by Angion Biomedica Corp
Sponsor:
ClinicalTrials.gov Identifier:
NCT02474667
First Posted: June 18, 2015
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Angion Biomedica Corp
  Purpose

A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of BB3 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 BB3 in reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.


Condition Intervention Phase
Delayed Graft Function Drug: BB3 Other: Placebo Phase 3

Study Type: Interventional
Study Design: 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 BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney

Further study details as provided by Angion Biomedica Corp:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Severity of DGF [ Time Frame: during Days 5-30, Days 8-30, Days 15-30, and Days 22-30 ]
    The severity of DGF assessed as the duration of dialysis.

  • The severity of DGF [ Time Frame: during Days 5-30, Days 8-30, Days 15-30, and Days 22-30 ]
    The severity of DGF assessed as the number of dialysis sessions.

  • Serum creatinine [ Time Frame: at Day 7, Day 14, Day 30, Day 60, Day 90, Day 180, and Day 360 ]
  • Estimated creatinine clearance [ Time Frame: at Day 7, Day 14, Day 30, Day 60, Day 90 and Day 180 ]
  • Estimated glomerular filtration [ Time Frame: at Day 7, Day 14, Day 30, Day 60, Day 90 and Day 180 ]
  • Incidence of dialysis [ Time Frame: within the first 7 days post-transplant ]
    Incidence of dialysis assessed by proportion of patients requiring dialysis.

  • The proportion of patients with a SCr > 3 mg/dL but who have not required dialysis [ Time Frame: within the first 5 days post-transplant ]
  • The proportion of patients with primary non-function (PNF) [ Time Frame: 60 days ]
    PNF is defined as a continuous requirement for dialysis for a least 60 days post-treatment.

  • Length of hospitalization following transplantation [ Time Frame: 60 days ]
  • Exploratory Endpoints - Serum Biomarkers [ Time Frame: at Screening, Day 1, Day 3, Day 7, Day 14, Day 30 ]
    Serum Biomarkers: C-reactive protein (CRP), neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1).

  • Exploratory Endpoints - Urine Biomarkers [ Time Frame: at Screening, Day 1, Day 3, Day 7, Day 14, Day 30 ]
    Urine biomarkers: NGAL and KIM-1.


Estimated Enrollment: 152
Study Start Date: January 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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. Oligo-anuric renal failure (less than 200 mL of UO per day) 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 < 35 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).
  8. Females of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year):

    Must have a negative serum pregnancy test prior to transplantation. Must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period OR agree to maintain total abstinence throughout the initial 30-day study period.

  9. Male patients must agree to use condoms or other suitable means of pregnancy prevention such as abstinence during the initial 30-day study period.
  10. Patient has poor renal function in the first 24 hours post-transplantation based on an average UO of less than 50 mL per hour over any 8 consecutive hours, to maximize the likelihood that the patient requires dialysis within the first 7 days post-transplant, irrespective of pre-transplant donor and recipient risk factors.
  11. Reason for low UO is not due to structural or vascular abnormalities which, when indicated should be confirmed with a renal ultrasound with Doppler study and/or vascular or urinary tract contrast studies.

Exclusion Criteria

  1. Signs and symptoms of volume depletion.
  2. Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
  3. Recipient of an ABO-incompatible kidney.
  4. Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
  5. Recipient of a kidney preserved by normothermic pulsatile machine perfusion.
  6. Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
  7. 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.
  8. Concurrent sepsis or active bacterial infection.
  9. Has an active malignancy or history 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.
  10. Female who is breastfeeding.
  11. History of positive human immunodeficiency virus test.
  12. Requires treatment with the CYP1A2 inhibitors, ciprofloxacin and/or fluvoxamine.
  13. Unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
  14. Not deemed medically appropriate for the study in the opinion of the Investigator.
  Contacts and Locations
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
Contact: Itzhak D. Goldberg,, MD, FACR 516-326-1200 igoldberg@angion.com
Contact: Michael Yamin, PhD myamin@angion.com

Locations
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Bunnapradist Suphamai, MD         
California Institute of Renal Research Recruiting
San Diego, California, United States, 92123
Contact: Barry Browne, MD    858-637-4800    BBrowne@bnmg.org   
United States, Colorado
University of Colorado Hospital Anschuts Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: James Cooper, MD         
United States, District of Columbia
Medstar Georgetown University Hospital Not yet recruiting
Washington, D.C., District of Columbia, United States, 20007
Contact: Mattew Cooper, MD    202-444-0753    matthew.cooper@gunet.georgetown.edu   
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Lloyd Ratner, MD    212-305-2813    lr2182@cumc.columbia.edu   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Saad Ehab, MD         
Sponsors and Collaborators
Angion Biomedica Corp
  More Information

Responsible Party: Angion Biomedica Corp
ClinicalTrials.gov Identifier: NCT02474667     History of Changes
Other Study ID Numbers: 001-15
First Submitted: June 12, 2015
First Posted: June 18, 2015
Last Update Posted: August 22, 2017
Last Verified: August 2017

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:
Delayed Graft Function
Pathologic Processes