A Study to Understand the ability and safety of GDC-8264 in Preventing kidney Injury and Major Adverse Kidney Events following Heart Surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genentech Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

28 Feb 2025 → 4 Mar 2026

Decision date (initial)

2025-02-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Genentech Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of GDC-8264 compared with placebo with respect to proportion of patients who develop major adverse kidney events at 90 days after surgery (MAKE90) To evaluate the safety of GDC-8264 compared with placebo

Secondary objectives 1

1. To evaluate the efficacy of GDC-8264 compared with placebo with respect to proportion of patients who develop AKI, Change in estimated glomerular filtration rate (eGFR) from baseline to post-operative day (POD) 30, 60, and 90, Incidence of new chronic kidney disease (CKD) at POD 90 or worsened baseline CKD by Grade 1 or more within 90 days after surgery, including from Stage 3a to 3b, proportion of patients who develop MAKE30 (within 30 days after surgery) and MAKE60 (within 60 days after surgery)

Conditions and MedDRA coding

Patients with moderate to high risk for cardiac surgery associated- acute kidney injury (CSA-AKI)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age > 40 years at time of signing Informed Consent Form
2. One of the listed 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), or mitral valve repair (MVr) - Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, or AVR+MVr Tricuspid annuloplasty at the time of mitral valve surgery, if deemed necessary by the investigator, would not preclude the patient from participating in this study
3. At least one or at least two of the following AKI risk factors Age > 70 years A history of CKD with eGFR < 60 mL/min/1.73m2 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 g/dL)
4. Stable kidney function as determined by the investigator with no known episodes of AKI within 2 weeks of screening
5. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
6. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion criteria 6

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 (patent foramen ovale and bicuspid aortic valve are not exclusions)
5. Heart transplant
6. Hypotension or shock requiring hospital admission

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Proportion of patients who develop MAKE90 defined as the occurrence of any of the following within 90 days after surgery: – Death – Requirement for dialysis – ≥ 25% decline in eGFR from baseline to Day 90 after surgery

Secondary endpoints 4

1. 1. Proportion of patients who develop AKI, defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria within 7 days after surgery
2. 2. Change in eGFR from baseline to POD 30, 60, and 90
3. 3. Incidence of new CKD at POD 90 or worsened baseline CKD by Grade 1 or more within 90 days after surgery, including from Stage 3a to 3b
4. 4. Proportion of patients who develop MAKE30 (within 30 days after surgery) and MAKE60 (within 60 days after surgery), defined as the occurrence of any of the following: – Death – Requirement for dialysis – ≥ 25% decline in eGFR from baseline to Day 30 and Day 60 after surgery

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genentech Inc.

Sponsor organisation

Genentech Inc.

Address

1 Dna Way

City

South San Francisco

Postcode

94080-4918

Country

United States

Scientific contact point

Organisation

Genentech Inc.

Contact name

US Program Manager Product Development Regulatory

Public contact point

Organisation

Genentech Inc.

Contact name

US Program Manager Product Development Regulatory

Third parties 3

Locations

6 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 55 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications