Summary

for people ages 18 years and up (full criteria)
at Los Angeles, California and other locations
study started
estimated completion

Description

Summary

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.

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

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. 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.

  1. Male patients must agree to use condoms or other suitable means of pregnancy prevention such as abstinence during the initial 30-day study period.
  2. . 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.
  3. . 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.

You CAN'T join if...

  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.

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • California Institute of Renal Research accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Angion Biomedica Corp
Links
Sign up for this study
ID
NCT02474667
Phase
Phase 3
Study Type
Interventional
Last Updated