GDC-8264 for Acute Kidney Injury

Recruiting at 25 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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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