Chronic kidney disease – Trials in Disease

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Ongoing Clinical Trials for Chronic Kidney Disease

There are currently 42 active clinical trials investigating new treatments and management strategies for chronic kidney disease. These studies are testing a range of medications and interventions aimed at slowing disease progression, protecting kidney function, and managing complications in patients with various stages of kidney disease, with or without accompanying conditions like diabetes, hypertension, and heart disease.

Clinical trial locations

Study of Sevuparin for Patients with Chronic Kidney Disease

This trial, conducted in Italy, is investigating sevuparin as a potential treatment for patients with chronic kidney disease. The study is designed in two parts and aims to develop dosing guidelines based on individual kidney function while monitoring changes in important blood and kidney health markers.

Main inclusion criteria: Participants must be adults aged 18-55 years with a BMI between 18.0 and 32.0 kg/m² and body weight of at least 50 kg. Patients with CKD must have stage 3, 4, or 5 disease (eGFR 15-45 mL/min/1.73m²) and be on stable medication regimens. Those in stage 4 and 5 must also have anemia.

Main exclusion criteria: The trial excludes patients with other serious medical conditions, pregnant or breastfeeding women, those who have had recent major surgery, participants in other clinical trials, individuals with allergies to similar medications, those with uncontrolled high blood pressure or severe liver disease, and patients with a history of substance abuse.

Trial focus: The study will examine how sevuparin affects blood and kidney function markers, specifically looking at changes after multiple doses. Researchers will closely monitor participants’ vital signs, blood tests, and kidney function throughout the study period.

Investigational drug: Sevuparin is administered as a subcutaneous injection (under the skin). It is being studied for its potential to improve kidney function and manage anemia in CKD patients by affecting blood components to improve circulation and reduce inflammation.

Study of vicadrostat and empagliflozin given together or separately in people with chronic kidney disease to test safety and effectiveness

This multinational trial is testing whether starting vicadrostat and empagliflozin (Jardiance) together works better than introducing them at different times in patients with CKD at risk of disease progression. The study will run for 14 weeks across multiple European countries including Poland, Czechia, Belgium, Spain, Germany, Netherlands, France, and Italy.

Main inclusion criteria: Participants must be 18 years or older with eGFR between 25-60 ml/min/1.73m² or 20-75 ml/min/1.73m² depending on albumin levels. They must have UACR between 100-5000 mg/g (or 80-100 mg/g with documented higher previous levels) and be on stable ACE inhibitor or ARB treatment at maximum tolerated dose for at least four weeks.

Main exclusion criteria: The trial excludes individuals outside the specified age range and those from vulnerable populations unable to provide informed consent.

Trial focus: The study will monitor kidney function through eGFR measurements and blood pressure at multiple timepoints (weeks 6, 12, and 14), comparing the effects of simultaneous versus staggered medication introduction.

Investigational drugs: Vicadrostat is a novel experimental medication being tested for kidney protection, while empagliflozin (Jardiance) is an established SGLT2 inhibitor that helps kidneys remove excess glucose. Both are oral tablets designed to slow CKD progression.

Study on Blood Pressure Management with Amiloride Hydrochloride, Indapamide, and Furosemide for Patients with Uncontrolled Hypertension and Chronic Kidney Disease

This French trial is examining whether intensifying blood pressure treatment with diuretics can reduce cardiovascular and kidney disease progression in patients with uncontrolled hypertension and moderate to severe CKD. The study will continue until January 2027.

Main inclusion criteria: Participants must be 18-79 years old with social security coverage and advanced CKD (eGFR 15.0-44.9 ml/min/1.73m²). They must have arterial hypertension treated with at least one renin-angiotensin system medication at maximum tolerated dose for at least one month, with blood pressure remaining above 140/90 mmHg in office and above 135/85 mmHg at home.

Main exclusion criteria: Patients with uncontrolled hypertension, moderate to severe CKD at risk for end-stage kidney disease, high mortality risk, or likely cardiovascular events are excluded.

Trial focus: The study will monitor kidney function decline, cardiovascular events, and mortality over up to 36 months, assessing quality of life using the PROMIS-29 questionnaire annually.

Investigational drugs: Diuretics including amiloride hydrochloride, indapamide, furosemide, and hydrochlorothiazide are being tested for their ability to help manage blood pressure and protect kidney function by helping the body eliminate excess salt and water.

Study on Chronic Kidney Disease and Polycystic Kidney Disease Using Pyruvic Acid and MRI for Patients with These Conditions

This Danish study is using advanced MRI imaging with hyperpolarized pyruvate to understand metabolic changes in the kidneys of patients with CKD and autosomal dominant polycystic kidney disease (ADPKD). The trial aims to identify markers of kidney damage through non-invasive imaging.

Main inclusion criteria: Participants must be 18-85 years old. For the PKD group, individuals must have ADPKD with eGFR greater than 60. For the CKD group, participants must have kidney disease from any cause except PKD and must have had a kidney biopsy within three months of the MRI scan. Women of childbearing age must have negative pregnancy tests.

Main exclusion criteria: Patients with other serious medical conditions, pregnant or breastfeeding women, participants in recent clinical trials, those with allergies to study substances, severe liver disease, substance abuse history, inability to undergo MRI scans, uncontrolled blood pressure, unstable heart disease, or inability to give informed consent are excluded.

Trial focus: The study will use MRI with hyperpolarized pyruvate to detect metabolic changes in kidneys, correlating these findings with measures of fibrosis, inflammation, and kidney function. Additional assessments include blood and urine tests and expired CO2 measurements.

Investigational drug: Hyperpolarized pyruvate is administered through injection to enhance MRI imaging, allowing researchers to visualize how kidneys process energy and identify abnormal metabolic patterns associated with disease progression.

Study on Dapagliflozin and Balcinrenone for Patients Over 50 with Stage 3 Chronic Kidney Disease

This trial, conducted in France and Germany, is investigating whether balcinrenone can maintain the beneficial effects of dapagliflozin on kidney glucose excretion in stage 3 CKD patients. The study will last up to 32 weeks and focuses on fluid and electrolyte balance.

Main inclusion criteria: Participants must be over 50 years old with stage 3 CKD (eGFR 30-60). German participants need serum potassium 3.5-5.0 mmol/L, while French participants need 3.5-5.0 mmol/L. Type 2 diabetes patients may participate if on stable doses of metformin, sulphonylureas, DPP4 inhibitors, or insulin for 12 weeks. BMI must be less than 40, and women of childbearing potential need negative pregnancy tests and effective contraception.

Main exclusion criteria: Stage 3 CKD patients outside the age range, those not in specified clinical trial groups, and vulnerable populations are excluded.

Trial focus: The study will monitor changes in urine glucose excretion, urine osmolality, muscle water content, and other parameters at day 3 and day 28, with regular safety evaluations.

Investigational drugs: Dapagliflozin is an SGLT2 inhibitor that helps kidneys remove glucose, while balcinrenone is a mineralocorticoid receptor antagonist being tested to see if it can preserve dapagliflozin’s benefits on glucose excretion while managing potassium levels.

Study on Dapagliflozin and Lifestyle Changes for Patients with Early Chronic Kidney Disease and Prediabetes

This German trial is testing whether dapagliflozin combined with lifestyle counseling can reduce albuminuria in patients with prediabetes and early CKD. The study will run for one year, comparing the medication plus lifestyle intervention against placebo plus lifestyle counseling.

Main inclusion criteria: Participants must be 35-75 years old with prediabetes (fasting glucose over 100 mg/dL, HbA1c over 5.6%, or 2-hour OGTT over 140 mg/dL) and early CKD (stage G1A2 or G2A2 with UACR 30-300 mg/g). BMI must be 20 kg/m² or higher, with normal TSH levels. Stable ACE inhibitor/ARB treatment for at least 6 weeks and stable other antihypertensive medication for 2 weeks are required. Thyroid replacement therapy must be stable for 3 months if applicable.

Main exclusion criteria: Advanced CKD, absence of prediabetes, age outside specified range, and vulnerable population status exclude participation.

Trial focus: The primary endpoint is reduction in albuminuria after one year. Regular monitoring will include kidney function tests, blood pressure measurements, and quality of life assessments.

Investigational drug: Dapagliflozin (an SGLT2 inhibitor) is taken as a 10 mg oral tablet daily. It works by preventing kidney glucose reabsorption, promoting glucose excretion in urine, and potentially reducing kidney damage in early-stage CKD with prediabetes.

Study on Dapagliflozin, Finerenone, and Semaglutide for Treating Chronic Kidney Disease in Patients

This multinational trial (Germany, Sweden, Spain, Italy, Denmark) is using a biomarker-targeted approach to compare personalized treatment with dapagliflozin, finerenone, or semaglutide against standard care. The study will last approximately two years, measuring treatment effects on kidney function decline.

Main inclusion criteria: Participants must be 18-75 years old with UACR 100-5000 mg/g (with specific variations based on medication use) and on stable ACE inhibitor or ARB treatment for at least four weeks. They must be able to communicate with study staff and provide informed consent.

Main exclusion criteria: Chronic kidney disease patients, those outside the age range, and vulnerable populations are excluded.

Trial focus: The study will measure changes in the chronic eGFR slope over 104 weeks, monitoring kidney function, proteinuria levels, and the KidneyIntelX score. Treatment is adjusted based on biomarker responses.

Investigational drugs: The trial tests three medications: dapagliflozin (oral), finerenone (oral), and semaglutide (subcutaneous injection). These drugs are being evaluated individually and in combination for their effectiveness in slowing kidney function decline based on personalized biomarker profiles.

Study on Finerenone for Children with Chronic Kidney Disease and Proteinuria Using ACEI or ARB

This extensive multinational pediatric trial (16 European countries) is evaluating finerenone’s effectiveness in reducing proteinuria in children aged 6 months to under 18 years with CKD. The six-month study will assess both safety and efficacy in this younger population.

Main inclusion criteria: Children must be 6 months to under 18 years with clinical CKD diagnosis (stages 1-3 for ages 1-18 years with eGFR ≥30 mL/min/1.73m², or serum creatinine ≤0.40 mg/dL for ages 6 months to under 1 year). They must have severely increased proteinuria with UPCR ≥0.50 g/g (ages ≥2 with CKD stage 2-3) or ≥1.0 g/g (ages under 2 or stage 1). Stable kidney function and optimized ACEI or ARB treatment for at least 30 days are required. Potassium levels must be ≤5.0 mmol/L (ages ≥2) or ≤5.3 mmol/L (ages under 2).

Main exclusion criteria: Children with proteinuria or chronic kidney disease outside the specified parameters are excluded.

Trial focus: The study will monitor urine protein excretion as the primary outcome, with regular assessments of kidney function, blood pressure, and potassium levels throughout the six-month treatment period.

Investigational drugs: Finerenone is administered orally as film-coated tablets or granules for oral suspension, with dosing adjusted based on age and body weight. It is being tested alongside ACEI or ARB medications to determine if it provides additional benefit in reducing proteinuria.

Study on How Tacrolimus Monohydrate and Mycophenolate Mofetil Affect Gut Bacteria in Patients with Chronic Kidney Disease After Transplant

This Belgian study is investigating how immunosuppressant medications interact with gut microbiota in kidney transplant patients with CKD. The trial aims to understand variability in drug processing and its relationship to changes in gut bacteria composition.

Main inclusion criteria: Participants must have chronic renal failure diagnosis, be scheduled for kidney transplantation from a living donor, receive care at Cliniques universitaires Saint-Luc, and be treated with tacrolimus (Advagraf) and mycophenolate mofetil (Cellcept). Age must be 18-75 years with BMI 18-35 kg/m².

Main exclusion criteria: Patients with chronic renal failure are excluded (note: this appears to be an error in the source data as the inclusion criteria require this condition).

Trial focus: The study will monitor drug levels in the body, examining pharmacokinetics (how the body processes medications), gut bacteria composition and function, and antibiotic pharmacokinetics. Regular monitoring continues until the study ends in December 2026.

Investigational drugs: Tacrolimus is a calcineurin inhibitor preventing organ rejection by suppressing T-cell activity, while mycophenolate mofetil is an antimetabolite that inhibits lymphocyte proliferation. Both are standard immunosuppressants, and the study examines how their processing varies with gut bacteria changes.

Study on Low Dose Rivaroxaban for Heart and Blood Vessel Disease in Patients with Advanced Kidney Disease or on Dialysis

This trial in Germany, France, and Belgium is testing whether low-dose rivaroxaban can reduce cardiovascular death and major cardiac events in advanced CKD patients (including those on dialysis) who have cardiovascular disease. The study will last up to 60 days initially, with long-term monitoring.

Main inclusion criteria: Participants must be at least 18 years old with either kidney failure requiring hemodialysis or peritoneal dialysis, or CKD stage 4 or 5 (not yet on dialysis). They must also have increased cardiovascular risk shown by at least one of: history of coronary artery disease, peripheral arterial disease, non-hemorrhagic stroke, diabetes mellitus, or age 65 or older.

Main exclusion criteria: Pregnant or breastfeeding women, severe allergic reactions history, active bleeding or high bleeding risk, severe liver disease, recent stroke or heart attack, certain medication interactions, and drug or alcohol abuse are excluded.

Trial focus: The study will monitor cardiovascular death, non-fatal heart attacks, strokes, and peripheral artery disease events. Regular health assessments will track kidney function, blood pressure, and overall cardiovascular status.

Investigational drug: Rivaroxaban 2.5 mg is an oral anticoagulant (blood thinner) taken twice daily. It works by inhibiting specific clotting proteins, thereby reducing harmful clot formation while being tested for safety in advanced kidney disease patients.

Study on Patiromer for Improving RAAS Treatment in Patients with Chronic Kidney Disease Stages 3b/4

This Dutch trial is investigating whether patiromer can enable the use of higher doses of RAAS-blocker medications by managing potassium levels in CKD stage 3b/4 patients. The study will last up to 12 months, examining whether this approach can reduce albuminuria more effectively.

Main inclusion criteria: Participants must be 18 years or older with CKD stage 3b or 4 (eGFR 15-44 mL/min/1.73 m²), albumin-creatinine ratio greater than 30 mg/mmol, systolic blood pressure higher than 130 mmHg or taking one or more antihypertensive medications, serum potassium 4.0-5.0 mmol/L, and taking sub-maximal doses of ACE inhibitors or ARBs.

Main exclusion criteria: Other serious health conditions, inability to follow procedures or take medication, pregnancy or breastfeeding, recent clinical trial participation, allergic reactions to study medication, severe liver disease, uncontrolled high blood pressure, drug or alcohol abuse, certain heart conditions, and kidney transplant history exclude participation.

Trial focus: The study will measure 24-hour urinary albumin excretion as the primary endpoint, with secondary assessments including blood pressure and kidney function metrics monitored at regular intervals.

Investigational drug: Patiromer is an oral powder that binds to potassium in the gastrointestinal tract, preventing absorption and helping maintain normal potassium levels. This allows for optimized RAAS-blocker dosing, potentially improving kidney protection.

Summary

The 42 ongoing clinical trials for chronic kidney disease represent a diverse and comprehensive research effort across Europe, with notable concentrations in countries like Germany, Italy, France, Spain, and the Netherlands. Several key therapeutic approaches emerge from these studies:

SGLT2 inhibitors feature prominently across multiple trials, with dapagliflozin being investigated in at least 10 different studies, both alone and in combination with other medications. This reflects the growing recognition of these drugs’ kidney-protective effects beyond their original diabetes indication.

Combination therapies are a major focus, with trials examining various drug pairings including dapagliflozin with finerenone, vicadrostat with empagliflozin, and zibotentan with dapagliflozin. These studies suggest a shift toward multi-drug approaches for slowing CKD progression.

Pediatric populations are well-represented, with dedicated finerenone trials across 16 European countries examining both short-term efficacy and long-term safety in children and young adults with CKD and proteinuria.

Specialized patient groups receive significant attention, including kidney transplant recipients (tacrolimus and mycophenolate studies), dialysis patients (rivaroxaban and dapagliflozin trials), and patients with specific conditions like type 1 diabetes, obesity, or polycystic kidney disease.

Novel approaches include biomarker-guided treatment selection, advanced imaging with hyperpolarized pyruvate, and investigations of drugs like patiromer to enable optimization of existing therapies. Several trials also address important comorbidities such as hypertension, cardiovascular disease, and metabolic disorders.

The geographic distribution demonstrates strong European collaboration, with many multinational studies facilitating faster recruitment and more diverse patient populations. The variety of trial designs—from short-term proof-of-concept studies to multi-year investigations—reflects different stages of drug development and aims to provide both rapid insights and long-term safety data.

Ongoing Clinical Trials on Chronic kidney disease

  • A study to test how well empagliflozin works and how safe it is for children and teenagers with chronic kidney disease

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    Belgium France Germany Hungary Italy The Netherlands +4
  • A study to compare the effects of BI 690517 and spironolactone on kidney function in patients with heart failure, cardiovascular disease, or chronic kidney disease

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    The Netherlands
  • Effect of levothyroxine on kidney function in patients at risk of hypothyroidism after partial thyroid surgery

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    Denmark
  • A study to evaluate the effect of baxdrostat and dapagliflozin in reducing protein in the urine for patients with chronic kidney disease and high blood pressure

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    Bulgaria Spain
  • A Study Testing How Well BAY 3401016 Works and How Safe It Is in Adults Aged 18 to 45 Years with Alport Syndrome

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    Czechia France Germany Italy Poland Portugal +1
  • A study testing finerenone compared to placebo in patients with chronic kidney disease who are not taking renin-angiotensin-system inhibitors

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    Spain
  • Study of semaglutide and finerenone for kidney and blood vessel protection in adults with chronic kidney disease, with or without diabetes

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    Denmark
  • Study on Tacrolimus and Sirolimus for Kidney Transplant Patients at High Risk of Cytomegalovirus Infection

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    Spain
  • Study of Sevuparin for Patients with Chronic Kidney Disease

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    Italy
  • Study on Chronic Kidney Disease and Polycystic Kidney Disease Using Pyruvic Acid and MRI for Patients with These Conditions

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    1 1
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    Denmark