Clinical Trials for Acute Kidney Injury
This article provides information about 12 ongoing clinical trials investigating treatments and prevention strategies for acute kidney injury. These studies are being conducted across multiple countries and examine various medications including cilastatin, dapagliflozin, angiotensin II, arginine-vasopressin, irbesartan, TIN816, glutamate infusion, nicotinamide, empagliflozin, and ravulizumab. The trials focus on patients at risk of kidney injury following cardiac surgery, liver transplantation, or those with sepsis-related kidney complications.
Clinical trial locations
- Austria
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Belgium
- Study on Dapagliflozin for Reducing Atrial Fibrillation and Kidney Injury in Patients Awaiting Coronary Artery Bypass Surgery
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Study on TIN816 for Preventing Acute Kidney Injury in Adults Undergoing Cardiac Surgery
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Czechia
- Study on Dapagliflozin for Reducing Atrial Fibrillation and Kidney Injury in Patients Awaiting Coronary Artery Bypass Surgery
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Study on TIN816 for Preventing Acute Kidney Injury in Adults Undergoing Cardiac Surgery
- Denmark
- Estonia
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France
- Study on the Effect of Arginine-Vasopressin and Noradrenaline Tartrate on Acute Kidney Injury in Liver Transplant Patients
- Study on the Effects of Irbesartan After Acute Kidney Injury in Patients Discharged from ICU
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Study on Nicotinamide for Patients with Acute Kidney Injury
- Study on Ravulizumab for Protecting Chronic Kidney Disease Patients from Acute Kidney Injury After Heart Surgery
- Study on TIN816 for Preventing Acute Kidney Injury in Adults Undergoing Cardiac Surgery
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Germany
- Study on Reducing Acute Kidney Injury After Heart Surgery Using Angiotensin II or Noradrenaline for Patients with Low Blood Pressure
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Study on Ravulizumab for Protecting Chronic Kidney Disease Patients from Acute Kidney Injury After Heart Surgery
- Study on TIN816 for Preventing Acute Kidney Injury in Adults Undergoing Cardiac Surgery
- Greece
- Hungary
- Italy
Study Comparing Cilastatin and Sodium Thiosulfate for Kidney Protection in Patients Undergoing Surgery with Chemotherapy Using Cisplatin
This trial, conducted in Spain, is investigating kidney protection strategies for female patients between 18 and 75 years old who are undergoing debulking surgery followed by heated chemotherapy with cisplatin. The study compares two medications: cilastatin and sodium thiosulfate, both given through intravenous infusion during surgery.
Inclusion criteria include female patients with an ECOG Performance Status of 2 who are suitable for major surgery. Patients must have disease confined to the abdomen, with certain limited exceptions for spread to nearby organs or lymph nodes. They must have nearly normal kidney function and blood counts before surgery.
Exclusion criteria include patients who already have kidney injury at the time of enrollment and male patients.
The main focus of the trial is monitoring kidney function for up to seven days after surgery by measuring creatinine levels in the blood. If kidney problems develop, monitoring continues for up to two weeks. The study uses the KDIGO scale to assess kidney health and compares how well each medication protects the kidneys during this complex cancer treatment.
The investigational drugs being tested are cilastatin, which prevents the breakdown of certain antibiotics in the kidneys, and thiosulfate, which helps neutralize harmful substances that can damage kidney tissue.
Study on Dapagliflozin for Reducing Atrial Fibrillation and Kidney Injury in Patients Awaiting Coronary Artery Bypass Surgery
This trial is being conducted in Denmark, Sweden, and Czechia, examining whether dapagliflozin, an SGLT2 inhibitor, can reduce the risk of irregular heartbeat and kidney injury in patients awaiting coronary artery bypass surgery. The medication is taken as a 10 mg film-coated tablet once daily.
Inclusion criteria require patients to be at least 18 years old with chronic coronary syndrome confirmed by coronary angiography. Patients must be scheduled for coronary artery bypass surgery using a heart-lung machine, possibly with additional valve procedures.
Exclusion criteria include recent heart attack, severe liver disease, severe allergic reactions to medications, participation in another trial, uncontrolled high blood pressure, severe kidney disease, pregnancy or breastfeeding, drug or alcohol abuse, certain cancers, and specific heart rhythm problems.
The trial’s goal is to determine whether dapagliflozin can prevent new onset atrial fibrillation and kidney injury after surgery. Patients are monitored throughout their hospital stay and for a period after discharge, with assessments including heart rhythm monitoring and kidney function tests.
The investigational drug dapagliflozin works by helping the kidneys remove sugar from the body through urine, and researchers believe it may also protect the kidneys and heart 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
This German trial compares angiotensin II with noradrenaline for managing low blood pressure after heart surgery, aiming to determine which medication better prevents kidney injury. Both medications are given through intravenous infusion for up to three days after surgery.
Inclusion criteria require patients to have undergone cardiac surgery using a heart-lung machine, including procedures like coronary artery bypass grafting or valve surgery. Patients must have an elevated risk of kidney injury based on a scoring system that considers factors like hemoglobin levels, creatinine levels, age over 70, heart failure severity, and obesity.
Exclusion criteria include patients who already have kidney injury before the study, those outside the specified age range, and vulnerable populations.
The study’s focus is monitoring kidney function within 72 hours after surgery by measuring changes in blood creatinine levels and urine output. Researchers will also track long-term outcomes including the need for dialysis and kidney function changes up to 120 days after surgery.
The investigational drugs are angiotensin II, which narrows blood vessels to increase blood pressure, and noradrenaline, which works similarly by stimulating certain receptors in the body.
Study on the Effect of Arginine-Vasopressin and Noradrenaline Tartrate on Acute Kidney Injury in Liver Transplant Patients
This French trial examines whether low-dose arginine-vasopressin can reduce the risk of kidney injury in patients undergoing liver transplantation. The medication is given as a solution through intravenous infusion during surgery.
Inclusion criteria require patients to be at least 18 years old and scheduled for liver transplantation. Patients must be affiliated with the Social Security system and able to provide informed consent.
Exclusion criteria include patients who have already had a liver transplant and those with existing kidney injury.
The trial’s purpose is to assess whether supplementing with arginine-vasopressin during liver transplant surgery can protect kidney function. Kidney health is monitored for the first seven days after surgery, with various measurements including blood transfusions needed, other medication use, and overall health status. Recovery is tracked for 30 days.
The investigational drug arginine-vasopressin is a hormone that helps regulate the body’s water balance and blood pressure, and researchers hope it can reduce kidney complications after liver transplants.
Study on the Effects of Irbesartan After Acute Kidney Injury in Patients Discharged from ICU
This French study evaluates whether irbesartan, an angiotensin receptor blocker, can improve heart and kidney health in patients recovering from kidney injury who are being discharged from intensive care. The medication is taken as a 150 mg film-coated tablet once daily for up to one year.
Inclusion criteria require patients to be at least 18 years old who experienced kidney injury during their ICU stay. Their kidney function must have stabilized for at least 48 hours, and they must be ready for discharge from the ICU or transitional care unit within 30 days. Patients must be affiliated with Social Security and agree to use effective birth control.
Exclusion criteria include patients who have not fully or partially recovered from kidney injury, those outside the specified age range, and vulnerable populations.
The study’s goal is to evaluate whether irbesartan reduces the risk of major heart-related events such as heart attacks or strokes and improves kidney function during the year following ICU discharge. Researchers will track kidney function changes, new episodes of kidney injury, and overall health status.
The investigational drug irbesartan works by blocking receptors that cause blood vessels to tighten, helping to relax blood vessels, lower blood pressure, and potentially protect both the heart and kidneys.
Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
This multi-country trial (France, Belgium, Czechia, Spain, Germany, Italy, Hungary, Austria) investigates TIN816, a new medication given through intravenous infusion, for treating kidney injury associated with sepsis. Sepsis is a severe infection that can damage multiple organs including the kidneys.
Inclusion criteria require patients between 18 and 85 years old who are admitted to an intensive care or high dependency unit with a diagnosis of sepsis and kidney injury at Stage 1 or higher. The diagnosis is based on a suspected or confirmed infection and a sudden increase in the SOFA score by 2 or more points, plus an increase in blood creatinine levels.
Exclusion criteria include patients without sepsis-associated kidney injury, those outside the age range, patients not part of specified clinical trial groups, and vulnerable populations.
The trial’s focus is exploring how different doses of TIN816 affect kidney function by measuring creatinine clearance from Day 1 to Day 8. The study also monitors for major adverse kidney events and changes in kidney function up to Day 90. Participants are randomly assigned to receive either TIN816 or a placebo in a double-blind manner.
The investigational drug TIN816 is designed to improve kidney function by enhancing the kidneys’ ability to filter waste from the blood, specifically by improving creatinine clearance.
Study on L-Glutamic Acid and Sodium Chloride to Prevent Acute Kidney Injury in High-Risk Heart Surgery Patients Without Diabetes
This Swedish trial examines whether L-glutamic acid infusion can prevent kidney injury and heart failure in non-diabetic patients undergoing coronary artery bypass surgery. The medication is given through intravenous infusion during surgery.
Inclusion criteria require adult patients without diabetes who are undergoing heart surgery using a heart-lung machine. Patients must have coronary artery bypass surgery involving at least two blocked vessels or a blockage in the main heart artery. They must have a EuroSCORE II of 3.0 or higher and a Left Ventricular Ejection Fraction of 0.30 or less.
Exclusion criteria include patients with diabetes, those not considered high-risk for kidney injury, patients who have not undergone coronary artery bypass surgery, those outside the specified age range, and vulnerable populations.
The study’s purpose is determining whether L-glutamic acid can effectively prevent kidney injury by monitoring creatinine levels before and after surgery. The trial also measures p-NT-proBNP levels, a marker related to heart function, from the day before surgery to the third day after.
The investigational drug glutamate is a substance that plays a role in cellular metabolism and may help improve energy production and reduce oxidative stress in tissues, potentially protecting kidney function during surgery.
Study on Nicotinamide for Patients with Acute Kidney Injury
This French trial tests whether nicotinamide, a form of vitamin B3, can help patients recover kidney function more effectively than standard care alone. The supplement is taken orally, with dosage determined by the study protocol.
Inclusion criteria require patients admitted to an adult intensive care unit or nephrology department who are at least 18 years old with persistent kidney injury Stage 2 or 3 despite 24 hours of standard care. Patients must have suspected acute tubular necrosis as the primary cause, be free from mechanical ventilation, have signed informed consent, and be affiliated with social security.
Exclusion criteria include patients who have had kidney transplants, are on dialysis, have chronic kidney disease Stage 4 or 5, have severe liver disease, are pregnant or breastfeeding, have a known allergy to nicotinamide, participated in another trial within 30 days, or have conditions making them unsuitable for the study.
The trial’s goal is determining if nicotinamide can lead to complete recovery of kidney function within 21 days, measured by checking the estimated glomerular filtration rate. Participants are randomly assigned to receive either nicotinamide or standard care in a double-blind manner.
The investigational drug nicotinamide influences cellular energy production and repair processes, which may help protect and restore kidney cells.
Study on Preventing Acute Kidney Injury After Heart Surgery Using Empagliflozin in Patients Undergoing Elective Cardiac Surgery
This Spanish trial examines whether empagliflozin, taken as a 10 mg film-coated tablet once daily around the time of surgery, can reduce the chances of developing kidney injury in patients having planned heart surgery involving a heart-lung machine.
Inclusion criteria require patients to be at least 18 years old with chronic coronary syndrome confirmed by coronary angiography and scheduled for elective coronary artery bypass surgery with extracorporeal circulation. Patients must understand the study’s purpose and provide written consent.
Exclusion criteria include patients not undergoing elective cardiac surgery with extracorporeal circulation, those outside the specified age range, vulnerable populations, patients with medical conditions or taking medications that could interfere with the study, pregnant or breastfeeding patients, those with allergic reactions to the study drug, and those participating in another clinical trial.
The study’s purpose is determining whether empagliflozin can reduce the incidence of kidney injury within 72 hours after surgery compared to placebo. Participants are monitored for up to 90 days following surgery to assess kidney function and overall health.
The investigational drug empagliflozin works by inhibiting a protein in the kidneys that helps remove excess sugar from the body through urine and may have protective effects on the kidneys during surgery.
Study on Ravulizumab for Protecting Chronic Kidney Disease Patients from Acute Kidney Injury After Heart Surgery
This multi-country trial (France, Poland, Spain, Germany, Italy, Netherlands, Portugal, Greece) investigates ravulizumab for preventing kidney problems in patients with chronic kidney disease undergoing heart surgery. The medication is given through intravenous infusion at a dosage of 300 mg/30 mL.
Inclusion criteria require patients between 18 and 90 years old weighing at least 30 kg who are scheduled for planned heart surgery requiring a heart-lung machine. This includes multiple vessel bypass surgery, valve procedures, or combined procedures. Patients must have chronic kidney disease with specific kidney function test results and be at risk for kidney problems after surgery with a minimum risk score of 2.8%.
Exclusion criteria include known allergy to the medication, current participation in another trial, history of severe allergic reactions, current or recent infection requiring antibiotics, certain cancers unless in remission, severe liver disease, drug or alcohol abuse within the past year, pregnancy or breastfeeding, and other medical conditions that would make participation unsafe.
The trial’s goal is seeing if ravulizumab can reduce the risk of kidney problems after surgery and improve overall kidney health. Participants are monitored over time to assess kidney function, recovery, and any side effects. The study is double-blind, with participants randomly receiving either ravulizumab or placebo.
The investigational drug ravulizumab works by blocking part of the immune system that can cause inflammation and damage to the kidneys.
Study on Preventing Acute Kidney Injury in Cardiac Surgery Patients Using Dapagliflozin
This Dutch trial examines whether Forxiga (dapagliflozin) 10 mg film-coated tablets, taken orally, can help prevent kidney injury in patients undergoing heart surgery. The study monitors patients for seven days after surgery and tracks various health outcomes.
Inclusion criteria require patients over 18 years old scheduled for elective cardiac surgery with cardio-pulmonary bypass or off-pump coronary artery bypass surgery who are able to give informed consent.
Exclusion criteria include individuals with a history of kidney injury, those outside the specified age range, vulnerable populations, and those not meeting other specific health criteria.
The study’s focus is determining how often kidney injury occurs within seven days after surgery, as well as evaluating changes in kidney function, heart health, recovery quality, and any side effects or complications. Various measurements are taken including blood sugar levels, heart function, and kidney health throughout the study.
The investigational drug dapagliflozin is an SGLT-2 inhibitor that blocks a protein in the kidneys, helping to lower blood sugar levels and potentially having protective effects on the kidneys during and after surgery.
Summary
These 12 clinical trials represent a comprehensive international effort to address kidney injury in various high-risk medical situations. The studies span multiple European countries, with France participating in six trials, followed by Spain and Germany with four each, demonstrating significant research concentration in these regions.
A notable trend is the focus on cardiac surgery-related kidney injury, with seven trials specifically examining patients undergoing heart procedures. This reflects the significant risk of kidney complications during and after cardiac surgery. Three trials investigate SGLT-2 inhibitors (dapagliflozin and empagliflozin), medications originally developed for diabetes that show promise for kidney protection. Additionally, two trials examine TIN816, a novel investigational drug being tested in both sepsis-related and cardiac surgery contexts.
The trials employ diverse preventive and therapeutic approaches, ranging from established medications used in new contexts (such as cilastatin, irbesartan, and ravulizumab) to nutritional supplements (nicotinamide and glutamate). Most studies use randomized, placebo-controlled designs to ensure robust scientific evidence. The research addresses different patient populations, including those with pre-existing chronic kidney disease, liver transplant recipients, and patients with sepsis, reflecting the broad scope of kidney injury risk across medical specialties.
