Clinical trial NCT06602453: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Kidney Injury
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 404
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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

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%

Primary outcomes:
measure: Percentage of Participants who Develop MAKE90
timeFrame: From Day 0 (day of surgery) up to Day 90 post-surgery
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Day 90 post surgery
Secondary outcomes:
measure: Percentage of Participants who Develop AKI
timeFrame: From Day 0 (day of surgery) up to Day 7 post surgery
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline up to Days 30, 60 and 90 post surgery
measure: Number of Participants With New or Worsened Chronic Kidney Disease (CKD)
timeFrame: Baseline up to Day 90 post surgery
measure: Percentage of Participants who Develop MAKE30 and MAKE60
timeFrame: From Day 0 (day of surgery) to Day 30, Day 60 post surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Stanford
country: United States
facility: University of Stanford Medical Center
state: California
city: New Haven
country: United States
facility: Yale School of Medicine Yale New Haven Hospital
state: Connecticut
city: Tampa
country: United States
facility: James A Haley Veteran Affairs Medical Center - NAVREF - PPDS
state: Florida
city: Springfield
country: United States
facility: Baystate Cardiac Surgery
state: Massachusetts
city: Lincoln
country: United States
facility: CHI Health Nebraska Heart
state: Nebraska
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Milwaukee
country: United States
facility: Aurora St Lukes Medical Center
state: Wisconsin
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Townsville
country: Australia
facility: Townsville Hospital
state: Queensland
city: Liege
country: Belgium
facility: Hopital de la Citadelle
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Angers
country: France
facility: CHU Angers
city: Paris
country: France
facility: APHP - Hopital de la Pitie Salpetriere
city: Reims
country: France
facility: CHU de Reims
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitatsklinikum
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: