Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Peyman Benharash, MD, FACS
Headshot of Peyman Benharash
Peyman Benharash

Description

Summary

The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developing AKI and subsequent MAKE at 90 days after surgery (MAKE90). The study will be performed in two parts- Part 1 and Part 2.

Official Title

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury and Major Adverse Kidney Events

Keywords

Acute Kidney Injury, Wounds and Injuries, GDC-8264

Eligibility

You can join if…

Open to people ages 40 years and up

  1. One of the following non-emergent cardiac surgery types that requires cardiopulmonary bypass (CPB) to be done in one procedure rather than separate procedures: Isolated Coronary Artery Bypass Grafting (CABG); Isolated Surgical Aortic Valve Replacement (AVR), Mitral Valve Replacement (MVR), Mitral Valve repair (MVr); Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, AVR+MVr
  2. At least one or at least two of the following AKI risk factors, depending on the type of surgery: age > 70 years, history of CKD with eGFR < 60 milliliters/ minutes/ 1.73 meter square (ml/min/1.73 m2) within the last 6 months, diabetes (type 1 or type 2) requiring at least one oral hypoglycemic agent or insulin, history of chronic obstructive pulmonary disease (COPD) requiring medical therapy, left ventricular ejection fraction (LVEF) < 40%, preoperative anemia [hemoglobin <10 grams/deciliters (g/dL)]
  3. Stable kidney function with no known episodes of AKI within 2 weeks of screening

You CAN'T join if...

  1. Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
  2. Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
  3. Presence of a durable left ventricular assist device
  4. Need for concurrent aortic surgery that requires circulatory arrest and deep hypothermia or repair of congenital heart defects
  5. Heart transplant
  6. Transcatheter valve replacements
  7. Hypotension or shock requiring hospital admission
  8. Cardiopulmonary resuscitation
  9. eGFR < 20 mL/min/1.73 m2
  10. Heart failure with ejection fraction < 20%, or episode of decompensated heart failure requiring intervention within 2 weeks prior to screening
  11. History of kidney transplant or only one kidney (due to donation)
  12. Renal agenesis, total nephrectomy, or partial nephrectomy of > 50%

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • University of Stanford Medical Center accepting new patients
    Stanford California 94305-2200 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
Links
Sign up for this study
ID
NCT06602453
Phase
Phase 2 Acute Kidney Injury Research Study
Study Type
Interventional
Participants
Expecting 404 study participants
Last Updated