Study of RMC-035 to prevent kidney injury in patients undergoing open-chest heart surgery

What is this study about?

This study focuses on preventing kidney injury in patients who undergo open-chest cardiac surgery. The research evaluates a new medication called RMC-035 (also known as ROSgard), which is given through an infusion. The medication is being tested to see how well it can protect kidney function in patients who are at high risk of developing kidney problems after heart surgery.

The study involves testing different doses of RMC-035 compared to placebo to find the most effective amount of medication for protecting kidney function. During the study, participants will receive either RMC-035 or placebo through an infusion into their veins. The maximum daily dose will be 120 milligrams, and the total treatment period will last up to 2 days.

After receiving the treatment, patients will be monitored for changes in their kidney function, particularly focusing on how well their kidneys are working 90 days after surgery. The medication being tested is a biological product that contains a modified version of a protein naturally found in the body. This protein has protective properties that may help prevent kidney damage during and after heart surgery.

1 Initial screening

Your kidney function will be measured using a blood test to calculate eGFR (estimated glomerular filtration rate).

A pregnancy test will be performed if you are a woman who can become pregnant.

Your medical history will be reviewed to confirm your eligibility for the study.

2 Preparation for cardiac surgery

You will be scheduled for a planned (non-emergency) open-chest cardiac surgery.

The surgery may include coronary bypass, heart valve repair/replacement, or ascending aorta surgery.

The surgery will use a heart-lung machine (cardiopulmonary bypass).

3 Study medication administration

You will receive either RMC-035 (study medication) or placebo through an IV infusion.

The medication is a clear, colorless to slightly yellow solution given as an infusion into your vein.

You will not know whether you receive the actual medication or placebo.

4 Follow-up period

Your kidney function will be monitored regularly after surgery.

The main assessment of your kidney function will occur at Day 90 after surgery.

You will need to use appropriate contraception during the study and for 7 days after the last dose of study medication.

5 Study completion

The study will evaluate how well the medication protects kidney function after cardiac surgery.

Your participation will help determine the optimal dose of RMC-035 for future patients.

The study is expected to continue until November 2025.

Who Can Join the Study?

Must be between 18 and 84 years old
Must have adequate kidney function with eGFR of at least 30 ml/min/1.73m2 (eGFR is a blood test that measures how well your kidneys are working)
Must be scheduled for planned (non-emergency) heart surgery with cardiopulmonary bypass, including:
- Coronary artery bypass surgery
- Heart valve surgery
- Surgery for an enlarged aorta
Must have specific risk factors for kidney problems, including either:
- Reduced kidney function (eGFR less than 60)
- Combined surgeries with at least one additional risk factor
- Single surgery with at least two additional risk factors like: heart problems, diabetes, age over 70, previous heart surgery, anemia, or previous kidney problems
For women:
- Must not be pregnant or breastfeeding
- Must use effective birth control if able to become pregnant
- Must agree not to donate eggs during the study and for 7 days after
For men:
- Must agree not to donate sperm during the study and for 7 days after
- Must use appropriate contraception or abstain from sexual activity
Must be able to understand and sign the informed consent form
Must agree not to participate in other clinical trials during the study

Who Cannot Join the Study?

Age below 18 years or above 85 years
Known severe allergic reactions to medications
Current participation in other clinical trials
Presence of chronic kidney disease (long-term kidney problems)
Pregnancy or breastfeeding
Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
Recent heart attack (within last 30 days)
Active infection or fever
Blood clotting disorders or current use of blood thinners
History of organ transplantation
Severe liver disease
Autoimmune diseases (conditions where the immune system attacks the body)
Active cancer or ongoing cancer treatment
Inability to provide informed consent
Severe mental health conditions that could affect participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Universitario Reina Sofía	Cordoba	Spain
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen	Munich	Germany
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Utrebfjlkfebbqhqctbkl Eepig Aet	Essen	Germany
Mwtyyzpiljmsxuhrfvuhoukkjc Hzelcatcdrhcvvny	Halle (Saale)	Germany
Hsdjncnl Ukuxonhlknqgw Do La Poeazopg	Madrid	Spain
Fqfputdd nocvbmjne Mjxnd a Hziuiej	Prague	Czechia
Uxlcweudkgyqecnvmbmuf Mtohbemj Aer	Munster	Germany
Hpqnyhid Dz Ln Sgjct Clww I Sjcr Pbc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.10.2024
Germany	Not recruiting	01.10.2024
Spain	Not recruiting	01.10.2024

Trial locations

Investigated drugs:

Rmc-035

RMC-035 is an investigational medication being studied to protect kidney function in patients who undergo open-chest cardiac surgery. This medication is designed to reduce the risk of kidney injury that can occur during and after heart surgery. It works to help maintain proper kidney function and may provide long-term kidney protection for patients who are at high risk of developing kidney problems following their cardiac surgery.

Investigated diseases:

Renal failure

Acute Kidney Injury After Cardiac Surgery – A condition where kidney function suddenly declines following heart surgery procedures. It occurs when the kidneys are damaged during or after cardiac surgery, leading to a decrease in their ability to filter waste products from blood. The condition typically develops within the first few days after surgery and can be identified through changes in urine output and blood tests. This type of kidney injury can affect the body’s ability to maintain proper fluid balance and remove waste products. The condition may be temporary, with kidney function gradually improving over time.

Cardiac Surgery-Associated Acute Kidney Injury – A specific form of kidney damage that develops as a complication of cardiac surgical procedures. The condition occurs when the kidneys experience stress during or after heart surgery, resulting in decreased kidney function and reduced ability to filter blood. It can develop due to changes in blood flow during surgery, inflammatory responses, and other surgery-related factors. The severity can range from mild kidney function decline to more significant impairment. This condition can affect fluid balance and waste removal in the body.

Trial ID:

2024-510658-28-00

Protocol code:

24-ROS-07

NCT ID:

NCT06475274

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of RMC-035 to prevent kidney injury in patients undergoing open-chest heart surgery

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