GDC-8264 for Acute Kidney Injury

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Genentech, Inc.

Prior Safety Data

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.

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.

Participant Groups

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.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: GDC-8264Experimental Treatment1 Intervention

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

Group II: Part 1: GDC-8264Experimental Treatment1 Intervention

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

Group III: Part 1: PlaceboPlacebo Group1 Intervention

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

Group IV: Part 2: PlaceboPlacebo Group1 Intervention

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