GDC-8264 for Acute Kidney Injury

Recruiting at 43 trial locations

Overseen By Reference Study ID Number: GC45428 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Disqualifiers: Renal replacement therapy, Heart transplant, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

404 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GDC-8264 to determine its effectiveness in preventing acute kidney injury (AKI) after heart surgery. AKI is a serious condition where the kidneys suddenly stop functioning properly. The trial compares GDC-8264 to a placebo to assess its effectiveness and safety. Individuals who have undergone specific types of heart surgery and are at risk for kidney problems may be suitable candidates for this trial, particularly if they have conditions like diabetes or chronic lung disease. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that GDC-8264 is likely to be safe for humans?

Research has shown that GDC-8264 was tested for safety in earlier studies. In these trials, researchers assessed how well participants tolerated both single and multiple doses of GDC-8264 compared to a placebo. The results indicated that participants generally tolerated the treatment well.

While participants did experience some side effects, they were mostly mild, meaning the treatment did not cause severe or dangerous reactions for most people. The current Phase 2 trial indicates that GDC-8264 showed enough promise in earlier safety tests to warrant further study. This phase aims to better understand its effects and safety in a larger group of people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acute kidney injury?

Most treatments for acute kidney injury (AKI) focus on managing symptoms and supporting kidney function, often relying on dialysis or medications like diuretics to relieve fluid overload. But GDC-8264 is different because it targets the underlying causes of kidney damage at a molecular level. Researchers are excited about GDC-8264 because it offers a new mechanism of action by inhibiting specific pathways that lead to inflammation and injury in the kidneys. This could potentially reduce the severity of AKI and improve recovery, offering hope for more effective and targeted care.

What evidence suggests that GDC-8264 might be an effective treatment for acute kidney injury?

Research has shown that GDC-8264 is under investigation as a method to prevent acute kidney injury (AKI) following heart surgery. In this trial, participants will receive either GDC-8264 or a placebo to assess its effectiveness. Researchers believe this treatment protects the kidneys during the stress of surgery. Early results suggest that GDC-8264 might reduce the risk of serious kidney problems, known as major adverse kidney events (MAKE). Although complete results from studies are still needed, the drug's mechanism offers hope for its effectiveness. Initial tests in the lab and on animals were promising, but more information from human studies is necessary to confirm its benefits. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for adults at moderate to high risk of acute kidney injury (AKI) after cardiac surgery. Eligible participants must have stable kidney function, be over 70 or have chronic kidney disease, diabetes, COPD, weak heart pump function, or preoperative anemia. They must be scheduled for certain types of heart surgeries with cardiopulmonary bypass.

Inclusion Criteria

My kidney function is stable with no recent acute kidney injury.

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 m\^2) 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 milligrans/ deciliters (mg/dL)}

I am scheduled for a specific heart surgery that involves a heart-lung machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive GDC-8264 or placebo as per a pre-defined dosing regimen in Part 1

Duration not specified

Treatment Part 2

Participants receive GDC-8264 or placebo as per a pre-defined dosing regimen in Part 2

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of MAKE at 90 days after surgery

90 days

What Are the Treatments Tested in This Trial?

Interventions

• GDC-8264

Trial Overview The study tests GDC-8264's effectiveness and safety in preventing AKI and major adverse kidney events within 90 days post-surgery compared to a placebo. It's conducted in two parts to see if the drug can help patients who've had heart surgery avoid serious kidney problems.

How Is the Trial Designed?

Group I: Part 2: GDC-8264 Experimental Treatment 1 Intervention

Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 2.

Group II: Part 1: GDC-8264 Experimental Treatment 1 Intervention

Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 1.

Group III: Part 1: Placebo Placebo Group 1 Intervention

Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.

Group IV: Part 2: Placebo Placebo Group 1 Intervention

Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06602453

A Study to Evaluate the Efficacy and Safety of GDC-8264 in ... A Study to Evaluate the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury (AKI) and Major Adverse Kidney Events (MAKE).

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/kidney-disorder/acute-kidney-injury/a-study-to-evaluate-the-efficacy-and-safety-of-gdc-8264-01033.html

Clinical trial for Acute Kidney Injury-Genentech A Member... The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery.

3. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/kidney-disorder/acute-kidney-injury/a-study-to-evaluate-the-efficacy-and-safety-of-gdc-8264-01033.pdf

A Study to Evaluate the Efficacy and Safety of GDC-8264 in ... 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 ...

4. trial.medpath.com trial.medpath.com/clinical-trial/6cf8605834dd5bbf/nct06602453-gdc-8264-cardiac-surgery-kidney-injury

A Study to Evaluate the Efficacy and Safety of GDC-8264 in ... 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 ...

5. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.5c01891

Discovery of Clinical Candidate GDC-8264, a Novel, Potent ... GDC-8264 is currently being tested in a Phase 2 trial for the prevention of cardiac surgery-associated acute kidney injury (CSA-AKI) in hopes of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10582670/

A phase I, randomized, ascending‐dose study to assess ... The primary objective of this first‐in‐human trial was to evaluate the safety and tolerability of single and multiple doses of GDC‐8264 compared with placebo in ...

7. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/pdf/10.1111/cts.13607

dose study to assess safety, pharmacokinetics, and activity of ... The primary objective of this first- in- human trial was to evaluate the safety and tolerability of single and multi- ple doses of GDC- 8264 ...