Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06602453




Registration number
NCT06602453
Ethics application status
Date submitted
17/09/2024
Date registered
19/09/2024
Date last updated
1/07/2025

Titles & IDs
Public title
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)
Scientific title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury and Major Adverse Kidney Events
Secondary ID [1] 0 0
2024-513125-23-00
Secondary ID [2] 0 0
GC45428
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GDC-8264
Treatment: Drugs - Placebo

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

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

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

Placebo comparator: Part 2: Placebo - Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.


Treatment: Drugs: GDC-8264
GDC-8264 will be administered as per pre-defined regimen.

Treatment: Drugs: Placebo
Placebo will be administered as per pre-defined regimen.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Develop MAKE90
Timepoint [1] 0 0
From Day 0 (day of surgery) up to Day 90 post-surgery
Primary outcome [2] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [2] 0 0
Up to Day 90 post surgery
Secondary outcome [1] 0 0
Percentage of Participants who Develop AKI
Timepoint [1] 0 0
From Day 0 (day of surgery) up to Day 7 post surgery
Secondary outcome [2] 0 0
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Timepoint [2] 0 0
Baseline up to Days 30, 60 and 90 post surgery
Secondary outcome [3] 0 0
Number of Participants With New or Worsened Chronic Kidney Disease (CKD)
Timepoint [3] 0 0
Baseline up to Day 90 post surgery
Secondary outcome [4] 0 0
Percentage of Participants who Develop MAKE30 and MAKE60
Timepoint [4] 0 0
From Day 0 (day of surgery) to Day 30, Day 60 post surgery

Eligibility
Key inclusion criteria
1. One of the following 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), Mitral Valve repair (MVr); Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, AVR+MVr
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 grams/deciliters (g/dL)]
3. Stable kidney function with no known episodes of AKI within 2 weeks of screening
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
5. Heart transplant
6. Transcatheter valve replacements
7. Hypotension or shock requiring hospital admission
8. Cardiopulmonary resuscitation
9. eGFR < 20 mL/min/1.73 m^2
10. Heart failure with ejection fraction < 20%, or episode of decompensated heart failure requiring intervention within 2 weeks prior to screening
11. History of kidney transplant or only one kidney (due to donation)
12. Renal agenesis, total nephrectomy, or partial nephrectomy of > 50%

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/11/2027
Actual
Sample size
Target
404
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 0 0
Townsville Hospital - Townsville
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
4810 - Townsville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Liege
Country [12] 0 0
Canada
State/province [12] 0 0
New Brunswick
Country [13] 0 0
Czechia
State/province [13] 0 0
Praha 2
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha 5
Country [15] 0 0
France
State/province [15] 0 0
Angers
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Reims
Country [18] 0 0
Germany
State/province [18] 0 0
Dresden
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
Cordoba
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Edinburgh
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GC45428 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06602453