Study on Ravulizumab for Protecting Chronic Kidney Disease Patients from Acute Kidney Injury After Heart Surgery

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What is this study about?

This clinical trial is focused on patients with Chronic Kidney Disease (CKD) who are undergoing heart surgery. The study aims to explore the effectiveness of a treatment called ravulizumab, also known by its code name ALXN1210, in preventing kidney problems that can occur after heart surgery. These kidney problems are known as Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and can lead to more serious kidney issues called Major Adverse Kidney Events (MAKE).

The study will compare the effects of ravulizumab with a placebo, which is a substance with no active medication. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The goal is to see if ravulizumab can reduce the risk of kidney problems after surgery. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Participants in the study will be monitored over a period of time to assess the impact of the treatment on their kidney health. The study will track various outcomes, including the occurrence of kidney injury and recovery, as well as overall health and any side effects. The findings from this study could provide valuable insights into improving care for patients with CKD undergoing heart surgery.

1 joining the study

Upon joining the study, you will be asked to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate. It includes details about the study’s requirements and restrictions.

2 initial assessment

You will undergo an initial assessment to confirm your eligibility. This includes checking your age, weight, and medical history related to chronic kidney disease and planned cardiac surgery. Your kidney function will be evaluated using specific tests.

3 randomization

You will be randomly assigned to receive either the study medication, ravulizumab, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you receive.

4 medication administration

If you are assigned to the ravulizumab group, you will receive the medication through an intravenous (IV) infusion. The dosage is 300 mg/30 mL, and the frequency and duration will be determined by the study protocol.

5 surgery and monitoring

You will undergo your planned cardiac surgery. After the surgery, your kidney function and overall health will be closely monitored. This includes regular assessments to check for any signs of acute kidney injury or other adverse events.

6 follow-up visits

You will have follow-up visits at specified intervals, such as days 30, 60, and 90 after the surgery. During these visits, your kidney function and general health will be evaluated. You may also be asked to complete questionnaires about your quality of life and fatigue levels.

7 study completion

At the end of the study period, your participation will conclude. You will have a final assessment to review your health status and any changes since the beginning of the study.

Who Can Join the Study?

  • Must be between 18 and 90 years old at the time of signing the consent form.
  • Can be male or female. Female participants who can have children and male participants must follow specific birth control guidelines.
  • Must have a body weight of at least 30 kg (about 66 pounds) at the time of screening.
  • Must be scheduled for planned, non-emergency heart surgery that requires a heart-lung machine. This includes:
    • Multiple blood vessel bypass surgery (CABG)
    • Heart valve replacement or repair
    • Surgery on the ascending aorta if combined with aortic valve replacement/repair
    • Combined CABG and valve surgery
    • Single-vessel CABG when combined with valve replacement/repair
  • Must have chronic kidney disease (CKD) or be suspected to have it, with specific kidney function test results (eGFR between 20 to less than 60 mL/min/1.73 m²).
  • Must be at risk for kidney problems after surgery, with a minimum risk score of 2.8% as assessed at screening.
  • Must be able to give signed informed consent and agree to follow the study requirements and restrictions.

Who Cannot Join the Study?

  • Patients who have a known allergy or sensitivity to the study medication or its ingredients.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe allergic reactions, known as anaphylaxis, to any medication.
  • Patients with a current or recent infection that requires treatment with antibiotics.
  • Patients with a history of certain types of cancer, unless they have been in remission for a specified period.
  • Patients with severe liver disease or liver function impairment.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who are pregnant or breastfeeding.
  • Patients with any other medical condition that the study doctors believe would make participation unsafe or affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hippokration Hospital Athens Greece
Medicover sp. z o.o. Medicover Opieka Szpitalna Centrum Leczenia Chorób Serca i Naczyń Medicover Warsaw Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Centro Cardiologico Monzino S.p.A. Milan Italy
Robert Bosch Krankenhaus GmbH Stuttgart Germany
Barmherzige Brueder Trier gGmbH Trier Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Athens Naval Hospital Athens Greece
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Gornoslaskie Centrum Mwdyczne Katowice Poland
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
University Hospital Consorziale Policlinico Bari Italy
Cerqkk Heymiaatdba Uhjnnatndtreg Du Dzwga Dijon France
Aqmvrk Mugrnwb Cpyhns Soss Thessaloniki Greece
Giptnm Umszbkoriw Ffvqwkhxj Frankfurt Germany
Cciyilkf Dc Miofnrnemc Montpellier France
Ktoginhf dwg Uizstsrggyoe Mwtadwvd Aqb Munich Germany
Uweyrcuvylxb Mhdswbv Cfuembj Gbqrbcwnp Groningen The Netherlands
Rvvbtrengp Sxonuaf Sregemcdcanfcjd Iuc Dxg Wdksmzizsl Bgntjvnmlsjf Grudziadz Poland
Afqusjvn Hwcur Og Pggovp Stif Tychy Poland
Uvxittjysgswd Svuiizy Kwagrhmsr Nx 2 Pjy W Ssjeyzckbt Szczecin Poland
Mggrkfgaiycgduqmbldkfcigdv Hsvcyxmbvurdvoow Halle (Saale) Germany
Mdcvmtpjhbj Comxhuf Srcbfpzhfsjqbwbmgq Acda Chrzanow Poland
Elcupfy Upabkfjjxtmg Mjkrhww Cgjnows Rpaswzzqv (dhytzqy Mnt Rotterdam The Netherlands
Udqwvupzedwqoadankbci Elisk Adm Essen Germany
Cgscxq Hixxnsjhwg E Unxyjopksoiie Dr Crdcqbw Eepdjp Coimbra Portugal
Hwoylfcs Vbvz dhlcuokg Barcelona Spain
Hehpgelq Urmllafmiwftf dk A Czlmzi A Coruna Galicia Spain
Kkhgecatv Sdjvkgb Sgoppuebjdkmadw io Joqb Pwsxj Ib Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
31.05.2023
Germany Germany
Not recruiting
31.05.2023
Greece Greece
Not recruiting
31.05.2023
Italy Italy
Not recruiting
31.05.2023
Poland Poland
Not recruiting
31.05.2023
Portugal Portugal
Not recruiting
31.05.2023
Spain Spain
Not recruiting
31.05.2023
The Netherlands The Netherlands
Not recruiting
31.05.2023

Trial locations

Investigated drugs:

Ravulizumab is a medication being studied for its potential to protect the kidneys during heart surgery. It is designed to help prevent acute kidney injury, which can happen when the kidneys are stressed during surgery. This medication works by blocking a part of the immune system that can cause inflammation and damage to the kidneys. The goal of using ravulizumab in this trial is to see if it can reduce the risk of kidney problems after surgery and improve overall kidney health in patients with chronic kidney disease.

Acute Kidney Injury – Acute Kidney Injury (AKI) is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. AKI can occur due to a variety of reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. The condition can lead to a decrease in urine output, swelling in the legs, ankles, and around the eyes, and fatigue. As AKI progresses, it can cause complications such as fluid retention, electrolyte imbalances, and increased pressure in the blood vessels. Recovery from AKI can vary, with some individuals experiencing full recovery while others may have lasting kidney damage.

Trial ID:
2022-501802-36-00
Protocol code:
ALXN1210-CSA-AKI-318
NCT ID:
NCT05746559
Trial Phase:
Therapeutic confirmatory (Phase III)

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