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Clinical Trials for Lupus Nephritis: Current Treatment Studies

There are currently 14 ongoing clinical trials investigating new treatments for lupus nephritis, a serious kidney complication of systemic lupus erythematosus. These studies are testing various medications including CAR T-cell therapies, monoclonal antibodies, and immunosuppressive drugs across multiple European countries and beyond, offering hope for patients who have not responded well to standard treatments.

Clinical trial locations

Study of CC-97540 CD19-targeted CAR T cells in patients with systemic lupus erythematosus who did not respond to previous immunosuppressive treatment

This trial is testing an innovative treatment called CC-97540, also known as CD19-Targeted NEX-T CAR T, for patients with systemic lupus erythematosus and lupus nephritis who have not responded well to standard treatments. The therapy uses specially modified immune cells from the patient’s own body that are designed to target specific disease-causing cells.

Inclusion criteria: Patients must be at least 16 years old and weigh at least 40 kilograms. They must have a confirmed diagnosis of systemic lupus erythematosus and have active lupus disease as measured by specific assessment tools. Importantly, patients must have previously tried treatment with steroids and at least two different immune-suppressing medications for at least 3 months each without adequate improvement. For patients with kidney involvement, a kidney biopsy performed within the past 6 months is required.

Exclusion criteria: Patients with active severe lupus nephritis requiring high doses of steroids or other strong medications cannot participate. Those with a history of severe allergic reactions to similar medications, current or recent serious infections including tuberculosis, hepatitis B or C, and HIV are excluded. Patients with significant uncontrolled heart, liver, or lung conditions, cancer diagnosis or treatment within the past 5 years, pregnancy, breastfeeding, or recent live vaccination are also excluded.

Treatment focus: Before receiving the main treatment, patients undergo preparation with three medications: cyclophosphamide, fludarabine, and tocilizumab. These are given through intravenous infusion to prepare the body for the CAR T cell treatment. The study evaluates whether CC-97540 can help patients achieve remission without needing other medications. Patients will be monitored through various tests including checking protein levels in blood, monitoring kidney function, and evaluating fatigue and pain levels.

Investigational drug: CC-97540 is a CAR T-cell therapy where a patient’s own T cells are modified in a laboratory to recognize and attack cells expressing CD19, a protein found on certain immune cells. The modified cells are then infused back into the patient to help control the disease.

Study on Anifrolumab for Adults with Active Lupus Nephritis

This double-blind, placebo-controlled trial is evaluating anifrolumab, a medication given through intravenous infusion, for adults with active proliferative lupus nephritis. The study aims to determine whether adding anifrolumab to standard care treatments can provide better outcomes for patients.

Inclusion criteria: Participants must be between 18 and 70 years old and weigh at least 40 kilograms. They must have a negative COVID-19 test result before screening. Women with an intact cervix must have had a normal cervical cancer screening within the last 2 years. Patients must meet updated criteria for systemic lupus erythematosus and have a positive test for antinuclear antibodies, anti-dsDNA, or anti-Sm antibodies. Active proliferative lupus nephritis Class III or IV with or without Class V must be confirmed by kidney biopsy within 6 months before consent or during screening. Patients must have elevated protein levels in urine and adequate kidney function.

Exclusion criteria: Patients with other serious health conditions that could interfere with the study, pregnancy, breastfeeding, history of severe allergic reactions to similar medications, certain prohibited medications, recent drug or alcohol abuse, active infections requiring treatment, recent live vaccination, history of certain cancers, and conditions affecting the immune system other than lupus nephritis are excluded.

Treatment focus: The study evaluates whether anifrolumab can help patients achieve a complete renal response by Week 52. This involves maintaining specific kidney function measurements including urine protein to creatinine ratio and estimated glomerular filtration rate. Secondary evaluations include sustained reduction in oral corticosteroid dosage and time to sustained complete renal response.

Investigational drug: Anifrolumab is administered intravenously and works by blocking the type I interferon receptor, which plays a role in the inflammation process associated with lupus. It is classified as a monoclonal antibody.

Study on Obinutuzumab for Adolescents with Active Lupus Nephritis and Safety in Children Aged 5 to 12

This trial is testing obinutuzumab for adolescents with active Class III or IV lupus nephritis and evaluating its safety in younger children aged 5 to under 12 years old. The medication is given through intravenous infusion.

Inclusion criteria: Participants must be adolescents aged 12 to under 18 years old or children aged 5 to under 12 years old. They must have active lupus nephritis Class III or IV confirmed by kidney biopsy done within the last 12 months or during screening. A positive test for antinuclear antibody or antibodies to double-stranded DNA is required either currently or historically. Patients can have Class V disease along with Class III or IV, but those with only Class V disease cannot participate. Significant proteinuria with a urine protein-to-creatinine ratio greater than 0.5 g/g is required. Patients must have received at least one dose of pulse-range IV methylprednisolone or equivalent medication within 12 months before or during screening.

Exclusion criteria: Patients who do not have lupus nephritis, those not within the specified age ranges, and those not part of the vulnerable population selected for the study cannot participate.

Treatment focus: Participants receive obinutuzumab as a 1,000 mg intravenous infusion or placebo at specified intervals. The treatment phase lasts up to 76 weeks. In addition to the study drug, participants may receive mycophenolate mofetil. Regular monitoring includes blood tests, urine tests, and assessments of kidney function. The primary goal is to assess the proportion of participants achieving a complete renal response.

Investigational drug: Obinutuzumab is a monoclonal antibody that targets and binds to a specific protein on the surface of certain immune cells, leading to their destruction. This helps manage lupus nephritis by reducing immune system activity.

Study on the Effectiveness and Safety of Iptacopan with Drug Combination for Adults with Active Lupus Nephritis Class III-IV, +/- V

This study evaluates the effectiveness and safety of iptacopan in combination with standard treatments for adults with active lupus nephritis Class III-IV, with or without Class V. The trial compares different doses of iptacopan with and without corticosteroids to standard care.

Inclusion criteria: Patients must be 18 years of age or older at screening. Vaccination against Haemophilus influenzae, Neisseria meningitidis, and Streptococcus pneumoniae infections is required before study treatment starts. All patients should be on supportive care including stable anti-malarials unless contraindicated. Patients should receive stable optimized ACE inhibitor or Angiotensin Receptor Blocker therapy at the locally approved maximum dose or highest tolerated dose. Both first presentation and flare of lupus nephritis patients can be included. COVID-19 vaccination according to local standards is mandatory. Patients must have a positive antinuclear antibodies test or positive anti-dsDNA test at screening. Active biopsy-proven lupus nephritis Class III or IV with or without co-existing Class V within 3 months before screening is required. Documentation of active kidney disease requiring corticosteroids combined with MMF/MPS is necessary, including positive dipstick for hematuria and confirmed proteinuria.

Exclusion criteria: Patients with different kidney disease than lupus nephritis Class III-IV cannot participate. Those not within the specified age range, unable to follow study procedures, with other serious health conditions, pregnant or breastfeeding, with recent infection or illness, or participating in another clinical trial are excluded.

Treatment focus: The study compares iptacopan 200 mg or 50 mg taken twice daily with or without tapering corticosteroids and either mycophenolate mofetil or mycophenolate sodium to standard care. The primary goal is to evaluate the proportion of patients achieving complete renal response at week 24 without kidney flares. Regular monitoring of kidney function and health parameters occurs throughout the study, which is expected to last until 2028.

Investigational drug: Iptacopan works by inhibiting a component of the immune system known as the complement pathway, which plays a role in inflammation and tissue damage. It is classified as a complement inhibitor and is administered orally.

Study on the Effects and Safety of Ianalumab in Adults with Lupus Nephritis Who Completed Previous Treatment

This extension study evaluates the safety and effectiveness of continuing or stopping ianalumab treatment in participants who completed a previous study called SIRIUS-LN. The study monitors for kidney flare recurrence or need for increased immunosuppressive medication.

Inclusion criteria: Patients must have signed an informed consent form before joining. They must have participated in the SIRIUS-LN core study and completed all treatments up to Week 144, whether on double-blind or open-label treatment. The study is open to both males and females and includes participants from vulnerable populations.

Exclusion criteria: Participants who have not completed the SIRIUS-LN core study cannot participate. Those who did not achieve complete renal response or partial renal response at Week 140 of the core study are excluded. Participants not receiving or who did not meet criteria for ianalumab treatment at the end of the SIRIUS-LN core study cannot participate.

Treatment focus: During the treatment phase, participants may receive ianalumab through subcutaneous injection. The study assesses safety and tolerability for those who were already receiving it or did not meet certain criteria in the previous study. Regular monitoring checks for renal flare or need for increased medication from Week 144E1 to Week 248. The study measures anti-ianalumab antibodies and ianalumab concentration in blood to understand how the body processes the medication.

Investigational drug: Ianalumab is administered as an injection, typically given under the skin. It works by targeting specific proteins in the immune system to reduce inflammation and immune response. It is classified as a monoclonal antibody.

Study on the Effects of Ianalumab with Standard Therapy for Patients with Active Lupus Nephritis

This Phase 3 trial compares ianalumab with placebo, both given alongside standard-of-care therapy including high-dose corticosteroids and mycophenolic acid, for patients with active lupus nephritis. The medication is administered as a subcutaneous injection using a pre-filled syringe.

Inclusion criteria: Adult male and female participants aged 18 years or older weighing at least 35 kg at screening are eligible. Patients must have a confirmed clinical diagnosis of systemic lupus erythematosus and a positive anti-nuclear antibody test at screening or documented positive result in the past. Active lupus nephritis at screening requiring treatment must be shown by kidney biopsy within 6 months before screening showing specific types of kidney inflammation, a urine test showing certain protein levels, and a kidney function test showing adequate function. Patients can be newly diagnosed or previously treated, including those who did not respond to previous treatments, as long as they are on or willing to start standard treatment using mycophenolic acid. Patients must have received at least one dose of specific steroid treatment for the current episode within 60 days before randomization. Signed informed consent is required.

Exclusion criteria: Patients with different kidney conditions other than lupus nephritis, those not within the specified age range, unable to follow study procedures, with other serious health conditions, pregnant or breastfeeding, participating in another clinical trial, with recent infection or illness, or history of drug or alcohol abuse are excluded.

Treatment focus: Participants receive either ianalumab or placebo in combination with standard-of-care therapy. The goal is to achieve a stable complete renal response by Week 72, involving maintaining kidney function and reducing protein levels in urine. Regular monitoring assesses effectiveness and safety, including measuring ianalumab concentration in blood and checking for antibodies. The primary goal is to evaluate the incidence of stable complete renal response at Week 72. Secondary evaluations include measuring time to achieve significant reduction in protein levels in urine and overall response rates at Week 48.

Investigational drug: Ianalumab is a monoclonal antibody that targets specific immune cells to reduce inflammation and prevent further kidney damage. It is administered as an injection.

Study on the Effects of Rapcabtagene Autoleucel in Patients with Systemic Lupus Erythematosus and Active, Refractory Lupus Nephritis

This trial compares rapcabtagene autoleucel, a CAR T-cell therapy, against standard treatments for patients with severe, difficult-to-treat lupus nephritis. The study aims to determine if this cell therapy can provide better outcomes than current standard treatments.

Inclusion criteria: Patients must sign a consent form and be men or women with systemic lupus erythematosus between 18 and 65 years old. They need to have certain antibodies in blood including antinuclear antibodies, anti-dsDNA, or anti-Sm. Active lupus nephritis confirmed by kidney biopsy is required, but it should not be a long-term issue. The urine protein creatinine ratio should be between 1.0 and less than 7.0 grams per gram in 24-hour urine collection. The SLEDAI-2K score measuring lupus activity should be 6 points or more. Patients should have tried at least two different treatments for lupus nephritis, each for at least 3 months, without adequate response.

Exclusion criteria: Patients with different conditions than systemic lupus erythematosus with active, difficult-to-treat lupus nephritis, those not within specified age range, not meeting gender requirements, or considered part of vulnerable populations needing special protection cannot participate.

Treatment focus: Participants are randomly assigned to receive either rapcabtagene autoleucel or standard of care. Before receiving the investigational treatment, participants undergo lymphodepletion involving administration of cyclophosphamide and fludarabine phosphate to reduce certain immune cells. Following lymphodepletion, participants receive a single infusion of rapcabtagene autoleucel administered intravenously. Regular monitoring assesses treatment effects and side effects. The primary goal is to evaluate clinical response at Week 52, focusing on remission and kidney function improvement. Secondary evaluations include fatigue levels, disease activity scores, and safety assessments.

Investigational drug: Rapcabtagene autoleucel is a gene therapy involving modification of a patient’s own T cells to help them better recognize and attack certain cells in the body. It is administered as a single infusion of CAR-positive viable T cells.

Study on the Safety and Effectiveness of MSV-allo for Patients with Lupus Nephritis

This double-blind trial studies MSV-allo, a cell therapy using mesenchymal cells delivered through intravenous injection, compared to placebo for patients with lupus nephritis. The study aims to evaluate safety and effectiveness in achieving complete or partial remission.

Inclusion criteria: Females or males aged 18 years or older who agree to participate by signing a consent form are eligible. Patients must have a diagnosis of systemic lupus erythematosus meeting specific criteria and lupus nephritis confirmed by kidney biopsy within the last 6 months or 1 year depending on situation. Patients who have not fully responded to standard treatments or have moderate to severe return of symptoms can participate. A SLEDAI-2K score of 10 or higher during screening is required. Women who can become pregnant must use effective birth control methods. Vaccinations against pneumococcus and influenza during appropriate times are required.

Exclusion criteria: Patients with different kidney conditions other than lupus nephritis, not within specified age range, part of vulnerable populations unable to give informed consent, unable to follow study procedures, with other medical conditions interfering with study results or safety, currently participating in another clinical trial, with recent changes in lupus treatment affecting study results, history of severe allergic reactions to study medications, pregnant or breastfeeding, or history of drug or alcohol abuse are excluded.

Treatment focus: The treatment involves administration of MSV-allo as a cell suspension for injection given through intravenous injection. The treatment period lasts 24 weeks, during which response to treatment is monitored, focusing on achieving complete or partial remission. Regular assessments monitor health status and treatment response. The primary endpoint is the proportion of patients achieving complete or partial response at week 24. Secondary assessments include evaluating changes in corticosteroid dosage, proteinuria levels, and quality of life scores.

Investigational drug: MSV-allo uses mesenchymal cells, a type of stem cell that can help reduce inflammation and promote healing. It is classified as a cell-based therapy focusing on immune modulation.

Study of Obinutuzumab and Mycophenolate Mofetil Without Oral Corticosteroids for Treatment of Lupus Nephritis

This trial compares two treatment approaches for lupus nephritis: mycophenolate mofetil with oral corticosteroids versus mycophenolate mofetil with obinutuzumab without additional oral corticosteroids. The study aims to determine if the obinutuzumab combination can work as well as traditional corticosteroid treatment while potentially reducing steroid exposure.

Inclusion criteria: Patients must be between 14 and 75 years old with active lupus nephritis confirmed by kidney biopsy within the last 8 weeks, showing Class III or IV with or without Class V affecting at least 10% of kidney filtering units. Elevated protein levels in urine measured by urine protein-to-creatinine ratio of 0.5 g/g or higher within 21 days before joining is required. Patients must be able to understand and sign informed consent. Women who can become pregnant must agree to use effective birth control for 18 months after starting. Patients must be registered in the French social security system.

Exclusion criteria: Patients below 18 or above 75 years old, with previous severe allergic reactions to biological medications, active or chronic infections, severe kidney disease requiring dialysis, history of cancer within past 5 years, pregnancy or breastfeeding, severe heart conditions or uncontrolled high blood pressure, current participation in other trials, major surgery planned during study, severe mental health conditions interfering with participation, live vaccines within 4 weeks before study, history of drug or alcohol abuse within past year, severe liver disease, use of prohibited medications, or inability to follow study procedures are excluded.

Treatment focus: Patients are randomly assigned to receive either MMF with oral corticosteroids or MMF with obinutuzumab. Obinutuzumab is given through intravenous infusion while MMF is taken as oral tablets. Throughout the study, doctors monitor kidney function by checking protein levels in urine and measuring how well kidneys filter blood. Regular medical evaluations track treatment response based on protein levels in urine and kidney function. The study measures how well kidneys respond to treatment after 52 weeks.

Investigational drugs: Obinutuzumab targets specific immune cells called B-cells that can contribute to inflammation and damage in lupus nephritis. Mycophenolate mofetil helps control the immune system’s response by reducing activity of certain immune cells. Corticosteroids reduce inflammation and suppress the immune system.

Study of Ravulizumab for Adults with Lupus Nephritis or IgA Nephropathy

This trial evaluates ravulizumab compared to placebo for adults with proliferative lupus nephritis or Immunoglobulin A Nephropathy. The medication is given through intravenous infusion and aims to assess effectiveness and safety in reducing protein levels in urine, a key indicator of kidney health.

Inclusion criteria: Patients must be between 18 and 75 years old with proteinuria of 1 or more. Vaccination against meningococcal infection, Haemophilus influenzae type b, and Streptococcus pneumoniae is required. For those with lupus nephritis, diagnosis of active focal or diffuse proliferative LN Class III or IV with clinically active disease requiring immunosuppression treatment is necessary. For those with Immunoglobulin A Nephropathy, diagnosis of primary IgAN following stable optimal RAS inhibitor treatment for at least 3 months is required.

Exclusion criteria: Patients with history of severe allergic reactions to study medication or similar drugs, currently participating in another clinical trial, history of certain cancers unless in remission for specified period, uncontrolled high blood pressure, severe liver disease, pregnancy or breastfeeding, certain uncontrolled infections, certain vaccines within specific time frame before study, history of drug or alcohol abuse interfering with study, or any other medical condition making participation unsafe are excluded.

Treatment focus: Participants receive ravulizumab through intravenous infusion with monitoring throughout the study. The treatment is compared to placebo to evaluate effectiveness in reducing proteinuria. Regular monitoring includes measuring percentage change in proteinuria and changes in estimated glomerular filtration rate. For lupus nephritis participants, additional assessments include percentage meeting criteria for complete or partial renal response, time to achieve specific urine protein to creatinine ratio, and percentage achieving corticosteroid tapering.

Investigational drug: Ravulizumab works by inhibiting the complement system, a part of the immune system playing a role in inflammation and tissue damage. It belongs to the class of complement inhibitors and is administered through intravenous infusion.

Summary

The landscape of lupus nephritis clinical trials shows extensive research activity with 14 ongoing studies investigating diverse therapeutic approaches. France and Germany emerge as major research hubs, hosting multiple trials that reflect strong commitment to advancing treatment options for this serious kidney complication of systemic lupus erythematosus.

The trials represent various stages of clinical development and test different types of medications. Several studies focus on innovative CAR T-cell therapies that modify patients’ own immune cells to target disease-causing cells. Monoclonal antibodies such as obinutuzumab, anifrolumab, and ianalumab are being studied across multiple trials for their ability to modulate immune responses. Complement inhibitors like iptacopan and ravulizumab represent another therapeutic approach targeting specific immune system pathways involved in kidney inflammation.

Most trials target adult patients with Class III or IV lupus nephritis who have not responded adequately to standard treatments including corticosteroids and immunosuppressive medications. Some studies include adolescent participants, reflecting recognition that lupus nephritis affects younger populations as well. The trials typically measure success by achieving complete or partial renal response, meaning improvement in kidney function and reduction in protein levels in urine.

Several studies specifically explore whether newer treatments can reduce or eliminate the need for high-dose corticosteroids, which carry significant side effects with long-term use. This steroid-sparing approach could improve quality of life for patients while maintaining disease control. The geographic distribution across European countries facilitates diverse patient recruitment and ensures research findings will be applicable across different populations and healthcare systems.

Ongoing Clinical Trials on Lupus nephritis

  • A long-term safety study of KYV-101 in patients previously treated for lupus nephritis, systemic sclerosis, myasthenia gravis, rheumatoid arthritis, or stiff person syndrome

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • A Study of Prednisolone, Mycophenolate Mofetil and Voclosporin Compared to Prednisolone and Mycophenolate Mofetil in Patients with Lupus Nephritis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effects and Safety of Ianalumab in Adults with Lupus Nephritis Who Completed Previous Treatment

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Hungary Romania Spain

  • Study on Obinutuzumab for Adolescents with Active Lupus Nephritis and Safety in Children Aged 5 to 12

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Poland Spain

  • Study on the Effects of Rapcabtagene Autoleucel in Patients with Systemic Lupus Erythematosus and Active, Refractory Lupus Nephritis

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Denmark France Germany Hungary +7

  • Study on the Safety and Effectiveness of MSV-allo for Patients with Lupus Nephritis

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of Iptacopan with Drug Combination for Adults with Active Lupus Nephritis Class III-IV, +/- V

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Hungary Portugal Spain

  • A Study of Obecabtagene Autoleucel for Patients with Severe Lupus and Active Kidney Inflammation Not Responding to Standard Treatment

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece

  • Study on the Effects of Ianalumab with Standard Therapy for Patients with Active Lupus Nephritis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Estonia France Germany Hungary Italy +3

  • Study of Ravulizumab for Adults with Lupus Nephritis or IgA Nephropathy

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland Spain +1

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