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Ongoing Clinical Trials for Acute Kidney Injury

There are currently 12 clinical trials investigating various treatments for acute kidney injury, a condition where the kidneys suddenly stop working properly. These studies are exploring medications including kidney-protective agents, blood pressure regulators, and diabetes drugs that may help prevent or treat this serious complication, particularly in patients undergoing major surgeries. Trials are being conducted across multiple European countries.

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    • Study Comparing Cilastatin and Sodium Thiosulfate for Kidney Protection in Patients Undergoing Surgery with Chemotherapy Using Cisplatin

    This trial is being conducted in Spain and focuses on protecting the kidneys during cancer surgery that uses heated chemotherapy. The study compares two kidney-protective medications: cilastatin and thiosulfate.

    Who can participate: Adult women aged 18 to 75 who are scheduled for major cancer surgery involving removal of tumors from the abdomen followed by heated chemotherapy with cisplatin. Participants must be healthy enough for major surgery, with adequate kidney function, normal blood counts, and cancer that is limited to the abdomen and can be completely removed.

    Who cannot participate: Male patients and those who already have kidney damage at the time of enrollment.

    What the study involves: The trial tests whether cilastatin provides similar kidney protection to thiosulfate during surgery involving cisplatin chemotherapy. Participants receive one of the two medications during their operation, and researchers monitor kidney function by measuring blood creatinine levels for up to two weeks after surgery.

    Investigational drugs: Cilastatin works by preventing the breakdown of antibiotics in the kidneys, potentially reducing kidney damage. Thiosulfate helps neutralize harmful substances that can damage the kidneys. Both medications are given through intravenous infusion during surgery.

    Study on Dapagliflozin for Reducing Atrial Fibrillation and Kidney Injury in Patients Awaiting Coronary Artery Bypass Surgery

    This study is taking place in Denmark, Sweden, and Czechia. It investigates whether dapagliflozin, a medication typically used for diabetes, can prevent irregular heartbeat and kidney injury after heart bypass surgery.

    Who can participate: Adults aged 18 and older who are scheduled for coronary artery bypass surgery, possibly combined with valve procedures. Participants must provide written consent.

    Who cannot participate: Patients with recent heart attacks, severe liver disease, severe kidney disease, uncontrolled high blood pressure, certain cancers, history of severe allergic reactions to medications, current participation in another trial, pregnancy or breastfeeding, or history of substance abuse.

    What the study involves: Participants receive either dapagliflozin 10 mg tablets or a placebo once daily during their hospital stay after surgery. The study monitors heart rhythm to detect irregular heartbeat and kidney function to check for damage, measuring these outcomes for up to 12 months after surgery.

    Investigational drug: Dapagliflozin is an SGLT2 inhibitor that helps the kidneys remove sugar from the body through urine. In this trial, it is being tested to see if it can protect both the heart and kidneys during the stress of surgery.

    Study on Reducing Acute Kidney Injury After Heart Surgery Using Angiotensin II or Noradrenaline for Patients with Low Blood Pressure

    Taking place in Germany, this trial compares two medications for managing low blood pressure after heart surgery to determine which better protects kidney function.

    Who can participate: Adults aged 18 and older undergoing heart surgery with a heart-lung machine, including coronary artery bypass or valve surgery, who have elevated risk of kidney injury based on specific scoring criteria.

    Who cannot participate: Patients who have recently experienced kidney injury, are outside the specified age range, or are considered vulnerable populations.

    What the study involves: The trial compares Angiotensin II with Noradrenaline, both given through intravenous infusion to manage blood pressure. Researchers monitor whether moderate or severe kidney injury develops within 72 hours after surgery, with follow-up assessments continuing for 90 days.

    Investigational drugs: Angiotensin II and Noradrenaline both work by narrowing blood vessels to increase blood pressure. The study aims to determine which medication provides better kidney protection while maintaining adequate blood pressure after surgery.

    Study on the Effect of Arginine-Vasopressin and Noradrenaline Tartrate on Acute Kidney Injury in Liver Transplant Patients

    This French study examines whether low-dose arginine-vasopressin given during liver transplantation can reduce the risk of kidney injury after surgery.

    Who can participate: Adults aged 18 and older scheduled for liver transplantation who are affiliated with the French Social Security system and provide informed consent.

    Who cannot participate: Patients who have already had a liver transplant or currently have kidney injury.

    What the study involves: During liver transplant surgery, participants receive either arginine-vasopressin or a placebo through intravenous infusion. The study monitors kidney function for seven days after surgery, tracking various health indicators including blood transfusion needs and overall health status.

    Investigational drug: Arginine-vasopressin is a hormone that helps regulate water balance and blood pressure in the body. By supplementing this hormone during surgery, researchers hope to improve kidney outcomes for liver transplant patients.

    Study on the Effects of Irbesartan After Acute Kidney Injury in Patients Discharged from ICU

    Conducted in France, this trial investigates whether Irbesartan, a blood pressure medication, can improve recovery and long-term health outcomes in patients who experienced kidney injury while in intensive care.

    Who can participate: Male and female patients aged 18 and older who had kidney injury during an ICU stay and whose kidney function has stabilized for at least 48 hours. Participants must be ready for discharge within 30 days and affiliated with the Social Security System. Women of childbearing potential and men must agree to use effective birth control.

    Who cannot participate: Patients who have not recovered fully or partially from kidney injury, those outside the specified age range, or individuals from vulnerable populations.

    What the study involves: Participants take either Irbesartan 150 mg tablets or a placebo once daily for up to one year after ICU discharge. The study monitors heart health and kidney function throughout this period, with regular check-ups to assess recovery and any complications.

    Investigational drug: Irbesartan is an angiotensin receptor blocker that relaxes blood vessels to lower blood pressure and protect the kidneys. This trial explores whether it can improve long-term outcomes for patients recovering from kidney injury.

    Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury

    This multi-country trial spans France, Belgium, Czechia, Spain, Germany, Italy, Hungary, and Austria. It investigates TIN816, a new medication being tested to improve kidney function in patients whose kidneys are damaged due to severe infection.

    Who can participate: Adults aged 18 to 85 who are admitted to intensive care or high-dependency units with diagnosed sepsis and Stage 1 or higher kidney injury, as confirmed by increased creatinine levels in the blood.

    Who cannot participate: Patients outside the specified age range, those not experiencing sepsis-related kidney injury, or individuals from vulnerable populations.

    What the study involves: Participants are randomly assigned to receive either TIN816 or a placebo, both given through intravenous infusion. The study monitors kidney function by measuring creatinine clearance from Day 1 to Day 8, with follow-up assessments continuing until Day 90 to evaluate long-term outcomes and safety.

    Investigational drug: TIN816 is designed to enhance the kidneys’ ability to filter waste from the blood. This trial evaluates whether it can effectively improve kidney function in patients with sepsis-related kidney injury.

    Study on L-Glutamic Acid and Sodium Chloride to Prevent Acute Kidney Injury in High-Risk Heart Surgery Patients Without Diabetes

    This Swedish study tests whether L-Glutamic Acid infusion during coronary artery bypass surgery can prevent kidney injury and heart complications in high-risk patients who do not have diabetes.

    Who can participate: Adults without diabetes undergoing heart surgery with a heart-lung machine, involving at least two blocked vessels or a major artery blockage. Participants must have a EuroSCORE II of 3.0 or higher and a left ventricular ejection fraction of 0.30 or less, indicating significant heart weakness.

    Who cannot participate: Patients with diabetes, those not at high risk for kidney injury, individuals who have not undergone coronary artery bypass surgery, those outside the age range, or vulnerable populations.

    What the study involves: Participants receive either L-Glutamic Acid or a placebo through intravenous infusion during surgery. The study monitors kidney function by measuring creatinine levels and heart function markers before and after surgery, with follow-up through June 2027.

    Investigational drug: Glutamate infusion may help protect the kidneys by supporting cellular energy production and reducing stress on tissues during surgery. This trial aims to determine if it can effectively reduce kidney and heart complications.

    Study on Nicotinamide for Patients with Acute Kidney Injury

    This French trial explores whether nicotinamide, a form of vitamin B3, can help patients recover kidney function more effectively than standard care alone.

    Who can participate: Adults aged 18 and older admitted to intensive care or nephrology departments with Stage 2 or 3 kidney injury that persists despite 24 hours of standard treatment. Participants must be free from mechanical ventilation, have acute tubular necrosis as the primary cause of injury, and be affiliated with the Social Security system.

    Who cannot participate: Patients with kidney transplants, those currently on dialysis, individuals with severe chronic kidney disease (Stage 4 or 5), severe liver disease, pregnancy or breastfeeding, known allergy to nicotinamide, participation in another trial within 30 days, or any condition making them unsuitable for the study.

    What the study involves: Participants receive either nicotinamide supplements or continue with standard care alone. The study measures whether complete kidney recovery occurs within 21 days, defined by achieving adequate kidney filtration rates.

    Investigational drug: Nicotinamide is a form of vitamin B3 that supports cellular functions. This trial tests whether supplementing with nicotinamide can enhance kidney healing after injury.

    Study on Preventing Acute Kidney Injury After Heart Surgery Using Empagliflozin in Patients Undergoing Elective Cardiac Surgery

    Taking place in Spain, this study investigates whether empagliflozin, a diabetes medication, can prevent kidney injury in patients undergoing planned heart surgery.

    Who can participate: Adults aged 18 and older scheduled for elective heart surgery requiring a heart-lung machine. Participants must understand the study purpose and provide informed consent.

    Who cannot participate: Patients not undergoing planned heart surgery with extracorporeal circulation, those outside the age range, vulnerable populations, individuals with interfering medical conditions or medications, pregnant or breastfeeding women, those with allergies to the study drug, or participants in other trials.

    What the study involves: Participants take empagliflozin 10 mg tablets or a placebo once daily around the time of surgery. The study monitors kidney function for 90 days after surgery, measuring various health outcomes including kidney filtration rates and overall recovery.

    Investigational drug: Empagliflozin is an SGLT2 inhibitor that helps kidneys remove excess sugar through urine. This trial explores whether it can also protect the kidneys from damage during and after heart surgery.

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

    This large international trial spans France, Poland, Spain, Germany, Italy, Netherlands, Portugal, and Greece. It examines whether ravulizumab can prevent further kidney damage in patients with existing chronic kidney disease who undergo heart surgery.

    Who can participate: Adults aged 18 to 90 weighing at least 30 kg who are scheduled for non-emergency heart surgery requiring a heart-lung machine. Participants must have chronic kidney disease with specific kidney function measurements and be at risk for post-surgical kidney problems. Both males and females who agree to birth control requirements can participate.

    Who cannot participate: Patients with known allergies to the medication, those currently in another trial, individuals with history of severe allergic reactions to any medication, current infections requiring antibiotics, recent cancer history (unless in remission), severe liver disease, substance abuse within the past year, pregnancy or breastfeeding, or other conditions the study team considers unsafe.

    What the study involves: Participants receive either ravulizumab or a placebo through intravenous infusion. The study monitors kidney function and health outcomes during surgery and for up to 90 days afterward, tracking kidney injury occurrence, need for dialysis, and overall recovery.

    Investigational drug: Ravulizumab is a monoclonal antibody that blocks part of the immune system that can cause inflammation and kidney damage. This trial tests whether it can protect kidneys during the stress of heart surgery.

    Summary

    The 12 ongoing clinical trials for acute kidney injury demonstrate diverse approaches to preventing and treating this serious condition. A notable concentration of research focuses on surgical settings, particularly heart surgery, with multiple trials examining kidney-protective strategies during and after cardiac procedures. France leads in the number of trials with six studies, followed by Spain and Germany with four each.

    Several trials investigate repurposing diabetes medications, specifically SGLT2 inhibitors like dapagliflozin and empagliflozin, for kidney protection. The experimental medication TIN816 appears in three separate trials across multiple countries, suggesting significant interest in this novel therapy. Other approaches include traditional blood pressure medications, hormone supplementation, vitamin therapy, and immune system modulators.

    The trials vary in their target populations, from patients undergoing specific surgical procedures to those with sepsis-related kidney injury or recovering from intensive care stays. Most studies focus on prevention rather than treatment of established injury, highlighting the medical community’s emphasis on protecting kidney function before damage occurs.

    Ongoing Clinical Trials on Injury

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