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

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for lupus nephritis, a condition where the immune system attacks the kidneys, causing inflammation and damage. The treatment being tested is called ianalumab, also known by its code name VAY736. This study is an extension of a previous study, and it aims to evaluate the safety and effectiveness of continuing or stopping the treatment in participants who have already completed the initial study.

Participants in this study will receive ianalumab through a solution for injection. The study will observe the participants over a period to see if there are any changes in their condition, such as a return of kidney problems or the need to increase other medications that suppress the immune system. The study will also monitor for any side effects or health changes that may occur during the treatment period.

In addition to ianalumab, the study involves other medications that participants may have been taking, such as mycophenolate mofetil, tenofovir alafenamide, emtricitabine, tenofovir disoproxil, and entecavir. These medications are typically used to manage immune system activity and viral infections. The study will help determine the best approach to managing lupus nephritis in the long term, either by continuing the treatment or by safely withdrawing it.

1 joining the study

Upon joining the study, ensure that you have signed the informed consent form. This confirms your understanding and agreement to participate in the study.

Participation requires completion of the previous SIRIUS-LN core study up to Week 144.

2 treatment phase

During the treatment phase, you may receive ianalumab through a subcutaneous route, which means it is administered under the skin.

The study will assess the safety and tolerability of ianalumab for those who were already receiving it or did not meet certain criteria in the previous study.

3 monitoring and assessments

Regular monitoring will occur to check for any renal flare or the need for increased medication. This will be observed from Week 144E1 to Week 248.

You will undergo assessments for any treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study.

4 antibody and concentration checks

The study will measure the presence and levels of anti-ianalumab antibodies in your blood from Week 144E1 to Week 248.

The concentration of ianalumab in your blood will also be monitored to understand how your body processes the medication.

5 completion of the study

The study is expected to continue until August 9, 2032. Your participation will contribute to understanding the long-term effects and safety of the treatment.

Upon completion, all data collected will be analyzed to assess the overall outcomes of the study.

Who Can Join the Study?

  • Must have signed an informed consent form before joining the extension study. This means you agree to participate after being told about the study’s details.
  • Must have taken part in the SIRIUS-LN core study and completed all treatments up to Week 144, whether on a double-blind or open-label treatment. Double-blind means neither you nor the researchers know if you are receiving the actual treatment or a placebo. Open-label means both you and the researchers know you are receiving the actual treatment.
  • Open to both males and females.
  • Participants can be from vulnerable populations, which means groups that might need special protection or care.

Who Cannot Join the Study?

  • Participants who have not completed the SIRIUS-LN core study.
  • Participants who did not achieve CRR or PRR at Week 140 of the core study.
    • CRR means Complete Renal Response, which is when the kidneys are working well again.
    • PRR means Partial Renal Response, which is when the kidneys are working better but not completely normal.
  • Participants who are not receiving or did not meet criteria for ianalumab treatment at the end of the SIRIUS-LN core study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hospital Edouard Herriot Lyon France
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Spitalul Clinic Judetean De Urgenta Bihor Oradea Romania
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
University Hospital Olomouc Olomouc Czechia
Fundeni Clinical Institute Bucharest Romania
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Szent Margit Korhaz Budapest Hungary
Cydngsfl Hqqanttddxjv Uahqtdiejwvna Dt Vnwq Vigo Spain
Arkepnmbjx Ppvtfzcp Hkzthwjn Dl Mwdiwedtb Marseille France
Bocnshkp Usjpiqagsp Hgfrebzy Cpzchg Besançon France
Cjba De Nigym Vandoeuvre Les Nancy France
Hpnrytql Vktu dychrnkn Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
29.05.2025
France France
Not yet recruiting
29.05.2025
Hungary Hungary
Recruiting
29.05.2025
Lithuania Lithuania
Not yet recruiting
29.05.2025
Romania Romania
Recruiting
29.05.2025
Spain Spain
Not yet recruiting
29.05.2025

Trial locations

Ianalumab is a medication being studied for its potential to help people with lupus nephritis, a condition where the immune system attacks the kidneys. In this trial, researchers are looking at how well ianalumab works and how safe it is for patients who have already participated in a previous study. The goal is to see if ianalumab can help maintain kidney health and prevent flare-ups of the disease. This medication is being tested to understand if it can be a long-term treatment option for people with this condition.

Lupus nephritis – Lupus nephritis is a kidney disorder that is a complication of systemic lupus erythematosus (SLE), an autoimmune disease. In this condition, the immune system mistakenly attacks the kidneys, leading to inflammation and potential damage. The disease progresses as the inflammation causes the kidneys to become less effective at filtering waste from the blood. Over time, this can lead to proteinuria, where protein leaks into the urine, and hematuria, where blood is present in the urine. As the condition advances, it may result in swelling, high blood pressure, and impaired kidney function. The severity and progression can vary widely among individuals, with some experiencing mild symptoms and others facing more significant kidney impairment.

Trial ID:
2024-515280-60-00
Protocol code:
CVAY736K12301E1
NCT ID:
NCT06711887
Trial Phase:
Therapeutic confirmatory (Phase III)

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