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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Stichting OLVG	Amsterdam	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Ziekenhuis Oost Limburg	Genk	Belgium
Hopital Beaujon	Clichy	France
Codoss Hiyqageirai Ulyinpmvpprhp Rtlkh	Reims	France
Ugdaxpjsrndltnjwhtnbn Ektzt Apb	Essen	Germany
Hyhriqnj Ujvrcqjibabyq Dn Ln Peqaruoc	Madrid	Spain
Fdwlgdbq nfadgwyxy Mvgkv a Hagbflt	Prague	Czechia
Aoaoothau Ufg	Amsterdam	The Netherlands
Uxbtqrlbnlapqkwcfouyn Mxwshuhk Adq	Munster	Germany
Csplhj Hmpwarnhsry Rvjntwtp Diaudayxqyognv	Angers	France
Hkzblnll Ukguzdexrdouz Hlfzxqts Tgzry y Pntupy Iikqrwoi Cceolt dbfhujtfdcanquddn (cnor	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	17.02.2025
Czechia	Not recruiting	17.02.2025
France	Not recruiting	17.02.2025
Germany	Not recruiting	17.02.2025
Spain	Not recruiting	17.02.2025
The Netherlands	Not recruiting	17.02.2025

Trial locations

Investigated drugs:

RO7288817

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.

Investigated diseases:

Acute kidney injury

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 ID:

2024-513125-23-00

Protocol code:

GC45428

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?