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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
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Angion Biomedica Corp

Tracking Information
First Submitted Date  ICMJE June 12, 2015
First Posted Date  ICMJE June 18, 2015
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2015)
Severity of DGF [ Time Frame: from the first day of study drug dosing (Day 1) until the last dialysis session or until Day 30 ]
The severity of DGF will be assessed by its duration as measured by the number of days a patient remains dialysis dependent.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2015)
  • 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 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, Day 180, and Day 360 ]
  • Incidence of dialysis [ Time Frame: for 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: for 5 days post-transplant ]
  • The proportion of patients with PNF [ Time Frame: 360 days ]
    PNF is defined as a continuous requirement for dialysis for a least 60 days post-treatment.
  • Length of hospitalization following transplantation [ Time Frame: 360 days ]
  • Exploratory Endpoints - Serum Biomarkers [ Time Frame: at Screening, Day1, Day3, Day7, Day1, Day30 ]
    Serum Biomarkers: C-reactive protein (CRP), neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) 2.
  • Estimated glomerular filtration rate [ Time Frame: at Day 7, Day 14, Day 30, Day 60, Day 90, Day 180, and Day 360 ]
  • Exploratory Endpoints - Urine Biomarkers [ Time Frame: at Screening, Day1, Day3, Day7, Day1, Day30 ]
    Urine biomarkers: NGAL and KIM-1.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Delayed Graft Function
Intervention  ICMJE
  • Drug: ANG-3777
    Other Names:
    • Hepatocyte growth factor mimetic
    • BB3
  • Other: Placebo
    Other Name: Normal saline
Study Arms  ICMJE
  • 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
    Intervention: Drug: ANG-3777
  • 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
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 24, 2021)
253
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2015)
152
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02474667
Other Study ID Numbers  ICMJE 001-15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angion Biomedica Corp
Study Sponsor  ICMJE Angion Biomedica Corp
Collaborators  ICMJE CTI Clinical Trial and Consulting Services
Investigators  ICMJE
Study Director: John Neylan, MD Angion Biomedica
PRS Account Angion Biomedica Corp
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP