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Kidney shield? experimental drug aims to prevent Post-Surgery kidney damage

NCT ID NCT06602453

Prevention Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a drug called GDC-8264 to see if it could prevent acute kidney injury and major kidney problems in people having heart surgery. The study enrolled 67 participants at moderate to high risk. However, the trial was terminated early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GDC-8264 (a drug given as a pill or injection)
What this could lead to
If it works, this could point toward a way to prevent kidney damage after heart surgery, reducing the need for dialysis and long-term kidney problems.
What could go wrong
The trial was terminated early, so results are limited. It was a small phase 2 study, and the drug may not prove effective or safe in larger groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

67 people

The number who actually took part.

Started

Jan 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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%

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury

Contacts and locations

Locations

  • APHP - Hopital de la Pitie Salpetriere

    Paris, 75013, France

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Baystate Cardiac Surgery

    Springfield, Massachusetts, 01107, United States

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14004, Spain

  • CHI Health Nebraska Heart

    Lincoln, Nebraska, 68526-9437, United States

  • CHU Angers

    Angers, 49933, France

  • CHU de Reims

    Reims, 51092, France

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Gold Coast University Hospital

    Southport, Queensland, 4215, Australia

  • Herzzentrum Dresden GmbH Universitatsklinikum

    Dresden, 01307, Germany

  • Hopital de la Citadelle

    Liège, 4000, Belgium

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario de La Princesa

    Madrid, 28006, Spain

  • James A Haley Veteran Affairs Medical Center - NAVREF - PPDS

    Tampa, Florida, 33612-4745, United States

  • John Hopkins Hospital

    Lutherville, Maryland, 21093, United States

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 55905-0001, United States

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Richmond VA Medical Center NAVREF PPDS

    Richmond, Virginia, 99999, United States

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA, United Kingdom

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2, Canada

  • Samsung Medical Center - PPDS

    Seoul, 06351, South Korea

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722, South Korea

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Townsville Hospital

    Townsville, Queensland, 4810, Australia

  • UZ Leuven

    Leuven, 3000, Belgium

  • University of Stanford Medical Center

    Stanford, California, 94305-2200, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-7202, United States

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808, Czechia

  • Waikato Hospital

    Hamilton, 3248, New Zealand

  • ZOL Genk campus Sint Jan

    Genk, 3600, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.