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Ongoing Clinical Trials for IgA Nephropathy

There are currently 22 clinical trials ongoing worldwide for IgA nephropathy, a kidney disease where immunoglobulin A proteins build up in the kidneys causing inflammation and damage. These studies are testing various investigational medications including atacicept, iptacopan, atrasentan, ravulizumab, sibeprenlimab, and others, aiming to reduce protein levels in urine and preserve kidney function. The trials are being conducted across Europe, with the majority taking place in Germany, Spain, Italy, France, Poland, and Belgium.

Clinical trial locations

Long-term safety and effectiveness study of atacicept in patients with IgA nephropathy (IgAN)

This trial focuses on testing the long-term safety of atacicept in patients who have previously participated in another study involving this medication. Atacicept is administered through subcutaneous injection, either using a pre-filled syringe or an auto-injector device.

Main inclusion criteria: Participants must have successfully completed a previous atacicept trial without safety issues. For those entering from a drug holiday period, blood pressure must be controlled below 150/90 mmHg, and kidney function must show an eGFR of at least 20 mL/min/1.73 m². Female participants must provide negative pregnancy tests at screening and on Day 1. Participants should be on stable doses of blood pressure medications unless they cannot tolerate them.

Main exclusion criteria: The trial excludes patients with a history of severe allergic reactions to biological medications, active or chronic infections including hepatitis B, C, or HIV, recent cancer history within 5 years, severe kidney dysfunction with eGFR below 30 mL/min, uncontrolled high blood pressure, blood clotting disorders, current participation in other trials, pregnancy or pregnancy plans, active liver disease, significant heart conditions, organ transplant history, current immunosuppressive treatment, recent live vaccinations, substance abuse history, or any condition deemed unsuitable by investigators.

Main focus and goals: The study will monitor participants’ kidney function and overall health through regular medical check-ups and laboratory tests over a treatment period lasting up to 156 weeks. The primary focus is evaluating long-term safety and tolerability by tracking side effects and measuring kidney function markers such as protein levels in urine and estimated glomerular filtration rate.

Investigational drug tested: Atacicept is a biological medication that targets specific proteins in the immune system to help regulate immune responses. It is designed to block certain molecules that contribute to inflammation and abnormal immune responses, potentially reducing kidney damage in patients with IgAN.

Long-Term Safety Study of Iptacopan for Adults with IgA Nephropathy After Completing a Previous Study, Including ACE Inhibitors and ARBs Drug Combination

This study examines the long-term safety of iptacopan in adults who have completed a previous trial. The medication is taken as hard gelatin capsules twice daily at a dose of 200 mg.

Main inclusion criteria: Participants must have completed all parts of a previous related study and be able to provide informed consent and follow study rules. Their kidney function, measured by eGFR, must be at least 20 mL/min/1.73 m². The study doctor must believe the participant could benefit from iptacopan treatment. Participants should be up to date with vaccinations against specific infections and must be on a stable dose of ACE inhibitors or ARBs unless they cannot tolerate these medications.

Main exclusion criteria: Patients with kidney conditions other than IgAN, those outside the specified age range, individuals unable to follow study procedures, those with other serious health conditions, pregnant or breastfeeding women, participants in other clinical trials, recent organ transplant recipients, and those with a history of drug or alcohol abuse are excluded.

Main focus and goals: The study will monitor long-term safety and tolerability through regular assessments of side effects, laboratory tests, vital signs, physical exams, and injection site reactions. Kidney function will be evaluated by measuring eGFR and changes in urine protein levels over approximately 12 and 24 months.

Investigational drug tested: Iptacopan is an oral medication that works by inhibiting a specific protein in the immune system called complement factor B, which helps reduce inflammation and damage in the kidneys.

Study on Atrasentan for Patients with IgA Nephropathy at Risk of Kidney Function Loss

This double-blind study tests atrasentan against placebo to evaluate its effectiveness in reducing protein levels in urine. The medication is taken as a film-coated tablet once daily.

Main inclusion criteria: Participants must be 18 years or older with confirmed primary IgAN diagnosis through kidney biopsy. They should be receiving the highest tolerable dose of RAS inhibitors, stable for at least 12 weeks, or have documented intolerance to these medications. Total urine protein must be at least 1 gram per day, and eGFR must be at least 30 mL/min/1.73 m². All fertile participants must agree to use highly effective contraception, with women having started hormonal contraceptives at least one month before enrollment.

Main exclusion criteria: The trial excludes patients with kidney conditions other than IgAN, those outside the specified age range, and individuals from vulnerable populations.

Main focus and goals: The study will monitor changes in proteinuria from baseline to Week 36 as the primary endpoint, with final kidney function assessments at Week 136 using eGFR measurements. Participants completing the double-blind portion may enter an open-label extension phase where all receive atrasentan for further safety evaluation.

Investigational drug tested: Atrasentan is an endothelin receptor antagonist administered orally in tablet form. It works by blocking endothelin receptors involved in blood vessel constriction and inflammation, potentially reducing kidney damage and proteinuria.

Study on Ravulizumab for Adults with Immunoglobulin A Nephropathy (IgAN) to Preserve Kidney Function

This trial evaluates ravulizumab administered through intravenous infusion to assess its effectiveness in reducing proteinuria and slowing kidney function decline compared to placebo.

Main inclusion criteria: Participants must be at least 18 years old with biopsy-confirmed IgAN diagnosis. They need controlled blood pressure below 140/90 mmHg and must maintain a stable, maximum tolerated dose of RASI medications for at least 3 months. Required vaccinations include meningococcal infection protection within the past 3 years, with antibiotic coverage if vaccinated less than 2 weeks before study start. Participants must have a UPCR of at least 0.75 g/g or UP of at least 1 g/day, an eGFR of at least 30 mL/min/1.73 m², hematuria evidence, and weigh at least 30 kg.

Main exclusion criteria: Exclusions include history of severe allergic reactions to study medication, other non-IgAN kidney diseases, kidney transplant recipients, uncontrolled high blood pressure, serious infections, pregnancy or breastfeeding, participation in other trials, and drug or alcohol abuse history.

Main focus and goals: The study monitors changes in proteinuria at Week 34 and assesses the rate of eGFR decline over 106 weeks. Regular assessments occur at Weeks 10, 26, 34, 50, and 106 to track kidney function and protein levels.

Investigational drug tested: Ravulizumab is a monoclonal antibody administered through intravenous infusion. It works by inhibiting the complement system, a part of the immune system that contributes to inflammation and kidney damage in IgAN.

Study on Ravulizumab for Children with IgA Nephropathy (Ages 2-17)

This pediatric trial studies ravulizumab in children aged 2 to under 18 years with primary IgAN. The medication is administered through intravenous infusion.

Main inclusion criteria: Children must be between 2 and 17 years old with legal guardian consent and child assent when appropriate. They need biopsy-confirmed IgAN or IgA Vasculitis Nephritis diagnosis. If taking immunosuppressive medications for IgAVN-related kidney issues, doses must be stable for at least 1 month. Required measurements include UPCR of at least 0.5 g/g and eGFR of at least 30 mL/min/1.73 m². Children must be on stable RASI doses for at least 3 months and weigh at least 10 kg. Vaccination requirements include meningococcal protection within 3 years and at least 2 weeks before first dose, plus Haemophilus influenzae type b and Streptococcus pneumoniae vaccinations according to guidelines.

Main exclusion criteria: Exclusions include severe allergic reactions to study medication, current participation in other trials, uncontrolled high blood pressure, active infections requiring antibiotics, certain cancer histories, organ transplants, severe liver disease, pregnancy or breastfeeding, substance abuse history, and major surgery within the last 3 months.

Main focus and goals: The study evaluates how ravulizumab behaves in children’s bodies and assesses its safety and effectiveness based on adult study knowledge. Regular monitoring includes physical examinations, blood and urine tests, and tracking of any side effects throughout the treatment period.

Investigational drug tested: Ravulizumab is a monoclonal antibody that blocks part of the immune system to reduce inflammation and kidney damage. It is designed to target specific proteins involved in the disease process.

Study on the Effect of Hydroxychloroquine for Patients with IgA Nephropathy and High Albumin Levels

This French trial compares hydroxychloroquine with placebo to determine if it can slow kidney function decline over three years. The medication is taken as a 200 mg film-coated tablet.

Main inclusion criteria: Participants must have social security affiliation and be over 18 years old with biopsy-confirmed IgAN diagnosis. They need a urine albumin/creatinine ratio greater than 300 mg/g and must be on the highest tolerated RAAS inhibitor dose for at least 3 months. Additionally, participants must be treated with both SGLT2i and RAAS therapy, have at least one Oxford lesion on their most recent biopsy, maintain an eGFR above 15 mL/min/1.73 m², and women of childbearing age must use highly effective contraception.

Main exclusion criteria: Exclusions include lack of confirmed IgAN diagnosis, albuminuria below 300 mg/g, absence of optimized RAAS inhibitor treatment, lack of Oxford lesions, age outside 18-65 years range, and vulnerable population status.

Main focus and goals: The study monitors changes in kidney function and proteinuria through regular follow-up visits at 1, 2, and 3 years. Blood, urine, and DNA samples are collected for analysis to assess treatment impact on kidney health and overall disease progression.

Investigational drug tested: Hydroxychloroquine is an oral medication primarily used for autoimmune diseases. It works by modulating the immune system and reducing inflammation, belonging to the antimalarial and disease-modifying antirheumatic drug classes.

Study on the Effectiveness and Safety of RO7434656 for Patients with Primary IgA Nephropathy at High Risk of Progression

This trial tests RO7434656, an antisense inhibitor of complement factor B, administered through subcutaneous injection to reduce proteinuria and slow disease progression.

Main inclusion criteria: Participants must have primary IgAN confirmed by kidney biopsy within the last 7 years or during screening, with no secondary causes. They should have been treated with maximum tolerated doses of ACE inhibitors or ARBs for at least 90 days, with short illness-related breaks allowed. Required measurements include UPCR of at least 1 g/g or urine protein excretion of at least 1 g/day, with UPCR being at least 0.8 g/g. Participants need an eGFR of at least 20 mL/min/1.73 m² and must be vaccinated against Neisseria meningitidis within 3 years, plus Streptococcus pneumoniae and Haemophilus influenzae according to national recommendations.

Main exclusion criteria: Exclusions include lack of primary IgAN diagnosis, age outside the specified range, unwillingness to follow procedures, interfering medical conditions, pregnancy or breastfeeding, participation in other trials, substance abuse history, recent major surgery or surgery plans, known allergies to study medication, and abnormal lab results indicating other health issues.

Main focus and goals: The study assesses changes in proteinuria at Week 37 and other outcomes at Week 105. Regular monitoring includes 24-hour urine collections, blood tests for kidney function, and eGFR calculations to track disease progression and treatment effectiveness.

Investigational drug tested: RO7434656 is an antisense oligonucleotide that targets and inhibits complement factor B, a protein in the immune system’s complement pathway. By blocking this factor, it aims to reduce inflammation and proteinuria in IgAN patients.

Study on the Long-term Safety and Effectiveness of Sibeprenlimab for Patients with Immunoglobulin A Nephropathy (IgAN)

This long-term extension study evaluates sibeprenlimab’s safety and effectiveness in participants who completed a previous trial. The medication is administered through subcutaneous injection.

Main inclusion criteria: Participants must have completed a previous sibeprenlimab trial without safety concerns, have an eGFR of at least 20 mL/min/1.73 m², and be able to provide written consent and follow study requirements. The trial doctor should believe the participant might benefit from continued sibeprenlimab treatment.

Main exclusion criteria: Exclusions include kidney conditions other than IgAN, current participation in other trials, kidney transplant history, serious infections requiring treatment, recent cancer history except certain treated skin cancers, known allergies to study medication, pregnancy or breastfeeding, and conditions deemed unsuitable by study doctors.

Main focus and goals: The study monitors long-term safety through assessment of side effects, laboratory tests, vital signs, physical exams, and injection site reactions. Kidney function is evaluated by measuring eGFR changes over approximately 12 and 24 months, along with urine protein level changes. The trial also tracks disease progression through serum creatinine levels and need for renal replacement therapy over 24 months.

Investigational drug tested: Sibeprenlimab is a monoclonal antibody administered through subcutaneous injection. It works by targeting specific pathways in the immune response to reduce inflammation and kidney damage, classified as an immunomodulatory agent.

Study on the Safety and Effects of Sparsentan for Children with Proteinuric Kidney Diseases

This pediatric trial studies sparsentan in children with various proteinuric glomerular diseases including IgAN. The medication is administered as an oral suspension once daily for 108 weeks.

Main inclusion criteria: Participants or their parent/legal guardian must provide signed informed consent and assent. Children must have an eGFR of at least 30 mL/min/1.73 m² and blood pressure within normal range for age, sex, and height. For Population 1, children must be at least 1 year but younger than 18, with UPCR of at least 1.5 g/g, and either a kidney biopsy showing specific patterns related to certain diseases with persistent proteinuria despite medication treatment, documentation of specific genetic mutations, or a biopsy showing specific patterns with matching medical history. For Population 2, children must be at least 2 years but younger than 18, with UPCR of 0.6 g/g or less, and either biopsy-confirmed disease or genetic testing diagnosis.

Main exclusion criteria: Exclusions include other serious health conditions, pregnancy or breastfeeding, recent major surgery, participation in other trials, substance abuse history, medication allergies, uncontrolled high blood pressure, severe liver or kidney disease, inability to follow procedures, and certain heart conditions.

Main focus and goals: The study evaluates safety and effectiveness by monitoring protein levels in urine, kidney function through various tests, and tracking any side effects over the 108-week treatment period. Regular assessments ensure participant safety while collecting data on treatment response.

Investigational drug tested: Sparsentan is administered orally as a suspension. It works by blocking both endothelin and angiotensin II receptors, which helps reduce blood pressure and protein leakage in the kidneys, classified as a dual receptor antagonist.

Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases

This trial tests atacicept in patients with various autoimmune kidney diseases including IgAN, administered through subcutaneous injection using a pre-filled syringe for 52 weeks.

Main inclusion criteria: Participants must be receiving stable standard care treatment according to local guidelines. Blood pressure requirements vary by age: adults must have systolic pressure of 160 mmHg or lower and diastolic pressure of 90 mmHg or lower, while those aged 10-17 must have blood pressure below the 95th percentile for their age, gender, and height. Participants must weigh at least 40 kg and agree to follow contraceptive guidelines. For IgAN patients specifically, they need biopsy confirmation or IgA vasculitis with nephritis, UPCR between 0.5 and 5 g/g, and adequate kidney function with eGFR of at least 20.

Main exclusion criteria: Exclusions include age below 18 or above 75 years, severe kidney dysfunction with eGFR below 30 mL/min/1.73 m², active or chronic infections, cancer history within 5 years, major surgery within 8 weeks, uncontrolled high blood pressure, severe heart disease, active liver disease, use of other investigational drugs within 30 days, substance abuse history, mental conditions interfering with participation, and any condition deemed unsafe by study doctors.

Main focus and goals: The study evaluates changes in protein levels in urine as the main outcome at Week 36, with final assessments at Week 52. Throughout the trial, kidney function is monitored through blood tests and urine protein measurements, with regular assessments of atacicept levels in blood.

Investigational drug tested: Atacicept is a biological medication administered through subcutaneous injection that targets and inhibits two proteins (BLyS and APRIL) involved in B-cell development. As a B-cell immunomodulator, it reduces harmful antibody production that can damage kidneys, classified as an immunosuppressive agent.

Study of felzartamab compared to placebo in adults with IgA nephropathy

This trial compares felzartamab administered through intravenous infusion against placebo to evaluate effectiveness in reducing proteinuria. Several supportive medications may be used to manage potential side effects.

Main inclusion criteria: Participants must have IgAN confirmed by kidney biopsy within the last 10 years (or last 24 months for type 2 diabetes patients). They need adequate kidney function with eGFR of at least 30 mL/min/1.73 m² for most patients, though 20-30 mL/min/1.73 m² may be accepted for specific groups. Participants should be on stable blood pressure medication doses (ACE inhibitors or ARBs) for at least 12 weeks or have documented intolerance. If taking other kidney disease medications, doses must be stable for at least 12 weeks. Required proteinuria levels are at least 1.0 gram in 24-hour urine collection or UPCR of at least 0.8 g/g. Both men and women 18 years or older can participate.

Main exclusion criteria: Exclusions include organ transplant history or transplant plans, active hepatitis B or C, HIV infection, current cancer or recent cancer treatment, other kidney diseases besides IgAN, severe allergic reaction history, pregnancy or breastfeeding, recent trial participation, severe heart disease, uncontrolled high blood pressure, recent serious infections, certain immune-affecting medications, recent alcohol or drug abuse, and any condition deemed unsafe by study doctors.

Main focus and goals: The study monitors changes in protein levels in urine and kidney function through regular blood and urine tests. Before each infusion, participants receive pre-medications including antihistamines, paracetamol, and methylprednisolone to prevent reactions. Long-term follow-up continues until June 2029, monitoring kidney function for signs of improvement or decline and documenting side effects.

Investigational drug tested: Felzartamab is a novel monoclonal antibody administered through intravenous infusion. It works by targeting and depleting specific immune cells that produce IgA antibodies, potentially reducing harmful antibody buildup in kidney tissue, representing a promising targeted approach for IgAN treatment.

Summary

The current landscape of IgA nephropathy clinical trials shows significant research activity across Europe, with 22 ongoing studies testing various therapeutic approaches. Germany, Spain, Italy, France, and Poland emerge as the primary research hubs, hosting the majority of these trials. This concentration reflects strong nephrology research infrastructure and patient populations in these countries.

Several investigational drugs are being extensively studied across multiple trials. Atacicept appears in three separate studies, including long-term safety evaluations and combination therapy approaches. Ravulizumab is being tested in four trials, including both adult and pediatric populations. Sibeprenlimab features in three studies focusing on long-term safety and effectiveness. Other notable medications under investigation include iptacopan, atrasentan, sparsentan, and felzartamab, each being evaluated in multiple trials with different patient populations and study designs.

The trials employ various administration methods, with subcutaneous injections and intravenous infusions being common for biological medications, while oral tablets are used for small molecule drugs. Study durations range from several months to several years, with many trials including long-term extension phases to gather comprehensive safety data.

Most trials focus on adults, though several studies specifically target pediatric populations, addressing the important need for treatment options in children with IgAN. The primary outcome measures typically include changes in proteinuria levels and kidney function preservation, reflecting the clinical priorities in IgAN management.

This diverse portfolio of clinical trials represents significant progress in developing new treatment options for IgA nephropathy patients, who currently have limited approved therapies. The geographic distribution across Europe facilitates patient access to these innovative treatments while contributing to the global understanding of IgAN management.

Ongoing Clinical Trials on IgA nephropathy

  • Study of Mezagitamab in Adults with Primary IgA Nephropathy (Berger’s Disease) to Reduce Protein in Urine

    Recruiting

    1 1
    Investigated diseases:
    Austria Czechia France Germany Hungary Italy +6

  • Study of felzartamab compared to placebo in adults with IgA nephropathy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Croatia Czechia France Germany +5

  • Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Poland Spain

  • Study on Ravulizumab for Children with IgA Nephropathy (Ages 2-17)

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study on Atrasentan for Patients with IgA Nephropathy at Risk of Kidney Function Loss

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Portugal Spain

  • Study on the Effect of Hydroxychloroquine for Patients with IgA Nephropathy and High Albumin Levels

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Long-Term Safety Study of Iptacopan for Adults with IgA Nephropathy After Completing a Previous Study, Including ACE Inhibitors and ARBs Drug Combination

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia Denmark France Germany Hungary +7

  • Study on the Safety and Effects of Sparsentan for Children with Proteinuric Kidney Diseases

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy The Netherlands Poland Spain Sweden

  • Long-Term Safety Study of Zigakibart in Adults with IgA Nephropathy Who Have Completed Previous Zigakibart Trials

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Croatia Czechia France Germany Greece +2

  • Study on the Effectiveness and Safety of Budesonide and Prednisone for Children with Primary IgA Nephropathy

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

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