RECRUITING

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)

Talk to us

Conditions

Acute Kidney Injury

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-01-17
Study Completion:2027-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06602453

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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 milligrans/ deciliters (mg/dL)}
  3. 3. Stable kidney function with no known episodes of AKI within 2 weeks of screening
  1. 1. Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
  2. 2. Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
  3. 3. Presence of a durable left ventricular assist device
  4. 4. Emergent cardiac surgery
  5. 5. Need for concurrent aortic surgery or repair of congenital heart defects
  6. 6. Heart transplant
  7. 7. Transcatheter valve replacements
  8. 8. Hypotension or shock requiring hospital admission
  9. 9. Cardiopulmonary resuscitation
  10. 10. eGFR \< 20 mL/min/1.73 m\^2
  11. 11. Heart failure with ejection fraction \< 20%, or episode of decompensated heart failure requiring intervention within 2 weeks of screening
  12. 12. History of kidney transplant or only one kidney (due to donation)

Contacts and Locations

Study Contact

Reference Study ID Number: GC45428 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Baystate Cardiac Surgery
Springfield, Massachusetts, 01107
United States
CHI Health Nebraska Heart
Lincoln, Nebraska, 68526-9437
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-17
Study Completion Date2027-11-15

Study Record Updates

Study Start Date2025-01-17
Study Completion Date2027-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Kidney Injury