Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Flavio Vincenti

Description

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.

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

Keywords

Delayed Graft Function DGF Renal Transplantation Deseased Donor Kidney BB3 Kidney Transplantation Acute Kidney Injury

Eligibility

You can join if…

Open to people ages 18 years and up

  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).

You CAN'T join if...

  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.

Locations

  • University of California San Francisco Medical Center accepting new patients
    San Francisco California 94143 United States
  • California Pacific Medical Center (Sutter) accepting new patients
    San Francisco California 94115 United States

Lead Scientist

  • Flavio Vincenti
    Professor, Medicine. Authored (or co-authored) 255 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Angion Biomedica Corp
ID
NCT02474667
Phase
Phase 3
Study Type
Interventional
Last Updated