Study on Ilofotase Alfa to Prevent Kidney Damage in Patients Undergoing Open Heart Surgery

What is this study about?

This clinical trial is focused on patients who are at risk of developing renal damage after undergoing open heart surgery. The study is investigating a treatment called Ilofotase alfa, which is given as a concentrate for solution for infusion, meaning it is administered directly into the bloodstream through a vein. The purpose of the study is to evaluate how effective and safe Ilofotase alfa is in protecting the kidneys during and after heart surgery.

Participants in the trial will be randomly assigned to receive either Ilofotase alfa or a placebo, which is a substance with no active medication. The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will monitor the participants’ kidney function by measuring levels of a substance called serum creatinine, which is a marker of kidney health, before and after the surgery.

Throughout the study, the safety of the participants will be closely monitored, and any side effects or adverse events will be recorded. The trial will also collect information on how the body processes Ilofotase alfa, known as pharmacokinetics. The study is expected to continue until 2025, with the aim of providing valuable insights into the potential benefits of Ilofotase alfa for patients undergoing heart surgery.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, planned type of heart surgery, and kidney function.

Participants must be at least 18 years old and scheduled for certain types of open-heart surgery using a heart-lung machine.

2 pre-surgery assessment

Before surgery, a baseline measurement of serum creatinine, a marker of kidney function, is taken.

This measurement helps to compare kidney function before and after surgery.

3 administration of ilofotase alfa or placebo

Participants receive either ilofotase alfa or a placebo through an intravenous infusion.

The medication is given as a concentrate for solution, specifically designed for infusion.

4 post-surgery monitoring

After surgery, kidney function is monitored by measuring serum creatinine levels on days 1, 2, 3, 4, and 5.

The goal is to assess any changes in kidney function compared to the baseline measurement.

5 follow-up period

Participants are monitored for any adverse events or side effects until day 28 after surgery.

This period includes tracking the incidence of any health issues that may arise.

Who Can Join the Study?

Must be 18 years or older.
Scheduled for specific types of open chest heart surgery using a machine that helps circulate blood during the operation. This includes:
- Combined valve and CABG surgery (a type of heart surgery).
- Aortic valve plus aortic root and/or ascending aorta surgery (excluding aortic arch).
- CABG with 3 or more connections to blood vessels.
Have a screening eGFR (a test that measures kidney function) between 25 and 65 mL/min/1.73m². This is calculated using a blood test that can be up to 28 days old.
Female patients who can have children must agree to use an effective birth control method during the treatment and for 14 days after. Women who are post-menopausal (over 60 years old or haven’t had a period for 12 months without another medical reason) do not need to use birth control.
Male patients must agree not to donate sperm and to use a male condom during sexual intercourse. If their partner can have children, they must also agree to use an effective birth control method during the treatment and for 14 days after.

Who Cannot Join the Study?

Patients who have a known allergy or bad reaction to the study medication or any of its ingredients.
Patients who are currently participating in another clinical trial or have recently participated in one.
Patients with severe liver disease, which means the liver is not working properly.
Patients with a history of drug or alcohol abuse, which means using drugs or alcohol in a harmful way.
Patients who are pregnant or breastfeeding, as the study medication might affect the baby.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen	Munich	Germany
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ziekenhuis Oost Limburg	Genk	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Ssyiwalud Reobomj Uedikahaxw Mvlhcve Cpnphm	Nijmegen	The Netherlands
Ewcuutu Uvakcwxvoxhv Mfrjgzi Ctorkfz Rgbtxypjl (rjajirt Mky	Rotterdam	The Netherlands
Airabttau Uio	Amsterdam	The Netherlands
Uvpcrmyusqlvgwyzsucdm Euhbt Aie	Essen	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.12.2023
Germany	Not recruiting	01.12.2023
The Netherlands	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

Ilofotase Alfa

Ilofotase Alfa is a medication being studied for its potential to protect kidney function in patients who are at risk of kidney damage after undergoing open heart surgery. The trial aims to evaluate how effective and safe this medication is in preventing or reducing kidney problems in these patients.

Risk for Renal Damage Following Open Heart Surgery – This condition involves the potential for kidney injury that can occur after undergoing open heart surgery. During such surgeries, the kidneys may be affected due to changes in blood flow, inflammation, or other stressors related to the procedure. The risk is often monitored by measuring levels of serum creatinine, a waste product filtered by the kidneys, to assess kidney function. An increase in serum creatinine levels post-surgery can indicate that the kidneys are not functioning properly. This condition requires careful monitoring to prevent further complications.

Trial ID:

2023-505859-45-00

Protocol code:

AP-recAP-CSA-RD-0201

NCT ID:

NCT06168799

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Ilofotase Alfa to Prevent Kidney Damage in Patients Undergoing Open Heart Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?