Ongoing Clinical Trials for Renal Injury
There are currently 2 ongoing clinical trials focused on preventing kidney injury in patients undergoing open-chest heart surgery. These studies are testing new medications designed to protect kidney function during and after cardiac surgical procedures. Trials are being conducted across multiple European countries including Germany, Spain, Czechia, Netherlands, and Belgium.
Clinical trial locations
- Belgium
- Czechia
- Germany
- Netherlands
- Spain
Study of RMC-035 to prevent kidney injury in patients undergoing open-chest heart surgery
This study is testing a medication called RMC-035 (also known as ROSgard) to help protect kidney function in patients who are at high risk of developing kidney problems after heart surgery. The medication is given through an infusion directly into the veins and contains a modified version of a protein that naturally occurs in the body with protective properties.
Who can participate:
- Adults between 18 and 84 years old
- Patients scheduled for planned (non-emergency) open-chest heart surgery using a heart-lung machine, including coronary artery bypass surgery, heart valve surgery, or surgery for an enlarged aorta
- Must have adequate kidney function with eGFR of at least 30 ml/min/1.73m² (a blood test measuring how well kidneys are working)
- Must have specific risk factors for kidney problems, such as reduced kidney function (eGFR less than 60), combined surgeries with additional risk factors, or single surgery with at least two risk factors like heart problems, diabetes, age over 70, previous heart surgery, anemia, or previous kidney problems
- Women must not be pregnant or breastfeeding and must use effective birth control if able to become pregnant
- Both men and women must agree not to donate sperm or eggs during the study and for 7 days after
Who cannot participate:
- People younger than 18 or older than 85 years
- Those with known severe allergic reactions to medications
- People with chronic kidney disease (long-term kidney problems)
- Pregnant or breastfeeding women
- Those with uncontrolled high blood pressure or recent heart attack within the last 30 days
- People with active infection or fever, blood clotting disorders, history of organ transplantation, severe liver disease, autoimmune diseases, or active cancer
What the study involves:
Participants will receive either RMC-035 or placebo through an IV infusion, without knowing which treatment they are receiving. The medication is given as a clear, colorless to slightly yellow solution. The maximum daily dose is 120 milligrams, and treatment lasts up to 2 days. After surgery, kidney function will be monitored regularly, with the main assessment occurring 90 days after surgery. This follow-up period helps determine how well the medication protects kidney function over time.
The study focuses on evaluating how effectively RMC-035 can prevent the sudden decline in kidney function that sometimes occurs after heart surgery. This type of kidney injury can affect the body’s ability to maintain proper fluid balance and remove waste products.
Study on Ilofotase Alfa to Prevent Kidney Damage in Patients Undergoing Open Heart Surgery
This clinical trial is investigating a treatment called Ilofotase alfa, which is designed to protect kidneys during and after open heart surgery. The medication is given as a concentrate solution directly into the bloodstream through a vein. The study is designed to be double-blind, meaning neither participants nor researchers know who receives the actual medication or placebo.
Who can participate:
- Adults 18 years or older
- Patients scheduled for specific types of open-chest heart surgery using a heart-lung machine, including combined valve and CABG surgery, aortic valve plus aortic root and/or ascending aorta surgery (excluding aortic arch), or CABG with 3 or more connections to blood vessels
- Must have screening eGFR (kidney function test) between 25 and 65 mL/min/1.73m², calculated using a blood test that can be up to 28 days old
- Women who can have children must agree to use effective birth control during treatment and for 14 days after (post-menopausal women over 60 or those without a period for 12 months do not need birth control)
- Men must agree not to donate sperm and to use condoms during sexual intercourse, with their partners also using effective birth control during treatment and for 14 days after
Who cannot participate:
- People with known allergy or bad reaction to the study medication or its ingredients
- Those currently participating in another clinical trial or who have recently participated in one
- People with severe liver disease
- Those with a history of drug or alcohol abuse
- Pregnant or breastfeeding women
- People with any other medical condition that study doctors think might make participation unsafe
What the study involves:
Before surgery, a baseline measurement of serum creatinine (a marker of kidney function) is taken to establish normal kidney function levels. Participants then receive either Ilofotase alfa or placebo through an intravenous infusion. After surgery, kidney function is closely monitored by measuring serum creatinine levels on days 1, 2, 3, 4, and 5 to assess any changes compared to the baseline measurement. Participants are monitored for any side effects or health issues until day 28 after surgery.
The study aims to evaluate how effective and safe Ilofotase alfa is in preventing or reducing kidney problems in patients undergoing heart surgery. At the molecular level, Ilofotase alfa works as an enzyme replacement therapy by breaking down harmful substances that can accumulate in the kidneys, thereby protecting kidney cells from damage.
Summary
Both ongoing clinical trials focus on the same critical issue: preventing kidney damage in patients undergoing open-heart surgery. These studies represent important research efforts to address a significant complication that can occur during and after cardiac surgical procedures.
The trials are primarily concentrated in Germany, where both studies are being conducted, reflecting the country’s strong involvement in cardiovascular and renal research. Other participating countries include Spain, Czechia, Netherlands, and Belgium, demonstrating a broad European collaborative effort.
The two studies test different investigational medications—RMC-035 and Ilofotase alfa—each with distinct mechanisms of action. RMC-035 uses a modified protein with protective properties, while Ilofotase alfa works as an enzyme replacement therapy to break down harmful substances in the kidneys. Both medications are administered through intravenous infusion.
A notable difference between the trials is the patient selection criteria. The RMC-035 study accepts patients with eGFR as low as 30 ml/min/1.73m² and includes a wider age range (18-84 years), while the Ilofotase alfa study focuses on patients with eGFR between 25 and 65 ml/min/1.73m² and requires participants to be 18 years or older without an upper age limit. Both studies require patients to have specific risk factors or be scheduled for particular types of cardiac surgery.
These trials provide valuable opportunities for patients at risk of kidney injury to access potentially protective treatments while contributing to medical knowledge that may benefit future cardiac surgery patients.
