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Study of GDC-8264 compared to placebo for preventing kidney injury in patients at risk of acute kidney injury after heart surgery

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on preventing Cardiac Surgery-Associated Acute Kidney Injury, a condition where the kidneys may become damaged after heart surgery. The study will test a medication called GDC-8264, given as film-coated tablets, compared to placebo in patients who are at moderate to high risk of developing kidney problems after heart surgery.

The purpose of the study is to determine if GDC-8264 can help prevent serious kidney-related complications that may occur within 90 days after heart surgery. These complications include death, need for dialysis (a procedure that filters blood when kidneys aren't working properly), or significant decline in kidney function. The study will also look at how well the kidneys work at different time points after surgery and monitor the development of Chronic Kidney Disease.

During the study, participants will undergo planned heart surgery that requires the use of a cardiopulmonary bypass machine, which temporarily takes over the function of the heart and lungs during surgery. Some participants will receive GDC-8264, while others will receive placebo. The study will monitor kidney function and overall health for 90 days after the surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    You will receive GDC-8264 or a placebo (inactive substance) before your heart surgery. This will be decided randomly, and neither you nor your doctor will know which one you receive.

    The medication will be given in the form of film-coated tablets that you take by mouth.

  2. Step 2

    Surgery day

    You will undergo one of these heart surgery procedures:

    - Coronary artery bypass grafting (CABG)

    - Surgical valve replacement or repair

    - A combination of these procedures

    The surgery will be performed using a heart-lung machine (cardiopulmonary bypass).

  3. Step 3

    First week after surgery

    Your kidney function will be monitored daily for the first 7 days after surgery.

    Medical staff will check for signs of kidney problems using blood tests.

  4. Step 4

    Follow-up period

    Your kidney function will continue to be monitored at day 30, 60, and 90 after surgery.

    The medical team will check for:

    - Changes in kidney function

    - Need for kidney dialysis

    - Development of chronic kidney problems

  5. Step 5

    Study completion

    The study ends 90 days after your surgery.

    Final assessment of your kidney function will be performed to compare with your initial status.

Who can join the trial?

13 criteria

  • Must be over 40 years old at the time of signing consent
  • Must be scheduled for one of these planned heart surgeries using heart-lung bypass machine:
    • Coronary bypass surgery alone (CABG)
    • Single heart valve replacement or repair
    • Combined bypass and valve surgery
    • Must have at least one of these risk factors:
      • Age over 70 years
      • Reduced kidney function (filtration rate below 60) in past 6 months
      • Diabetes requiring medication or insulin
      • Chronic lung disease requiring treatment
      • Heart pumping strength less than 40%
      • Low blood count (hemoglobin less than 10)
      • Must have stable kidney function with no kidney problems in the 2 weeks before screening
      • For women who can become pregnant: must agree to avoid sexual intercourse or use effective birth control
      • For men: must agree to avoid sexual intercourse or use condoms, and not donate sperm during the study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 85 years
  • Known severe allergic reactions or hypersensitivity to study medication or its components
  • Current participation in other clinical trials or within 30 days before enrollment
  • Kidney disease requiring dialysis
  • History of kidney transplantation
  • Severe liver disease (condition affecting liver function)
  • Expected survival less than 90 days
  • Pregnancy or breastfeeding
  • Inability to provide informed consent
  • Recent major surgery within past 30 days
  • Blood clotting disorders or current use of blood thinners
  • Uncontrolled high blood pressure (hypertension)
  • Active infection or fever within 7 days before surgery
  • History of drug or alcohol abuse within past 6 months
  • Mental conditions that could interfere with study compliance
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Investigated drugs

GDC-8264 is an investigational medication being studied for its potential to prevent kidney problems that can occur after heart surgery. This medication is being tested to see if it can reduce the risk of serious kidney complications that some patients experience within 90 days following cardiac surgery. The drug aims to protect kidney function during and after heart surgery procedures.

What is already known about the treatment

GDC-8264 - An investigational drug being studied in Phase II clinical trials for the prevention of cardiac surgery-associated acute kidney injury (CSA-AKI). The medication is being evaluated in a randomized, double-blind, placebo-controlled study for patients undergoing cardiac surgery who are at moderate to high risk of developing kidney complications. While the specific mechanism of action is still under investigation as part of the clinical trial process, the drug is being tested for its potential protective effects on kidney function during and after cardiac surgery. The primary goal is to reduce the occurrence of major adverse kidney events within 90 days post-surgery, with safety evaluations being a key component of the study.

Investigated diseases

  • Acute Kidney Injury (AKI)

    A sudden decline in kidney function that occurs over hours or days, characterized by decreased urine output and buildup of waste products in the blood. It commonly occurs as a complication after cardiac surgery due to reduced blood flow to the kidneys. The condition can range from mild to severe, affecting the kidneys' ability to filter waste from the blood. AKI may be temporary, with kidney function returning to normal after the underlying cause is addressed.

  • Chronic Kidney Disease (CKD)

    A gradual loss of kidney function that develops over months or years, where the kidneys become less efficient at filtering waste from the blood. The disease progresses through different stages (1-5), with stage 3 being divided into 3a and 3b, indicating moderate kidney damage. CKD can be caused by various underlying conditions and typically develops slowly over time. The condition leads to a progressive decline in estimated glomerular filtration rate (eGFR), which measures how well the kidneys filter blood.

  • Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI)

    A specific form of acute kidney injury that occurs as a complication following heart surgery. This condition develops due to various factors during cardiac surgery, including changes in blood flow to the kidneys, inflammation, and oxidative stress. The injury typically manifests within the first week after surgery and can vary in severity.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513125-23-00Protocol codeGC45428Estimated enrolment390 patientsSponsorGenentech Inc.

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