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

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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 medication is given as a solution for injection under the skin. The study will compare the effects of ianalumab with a placebo, which looks like the real treatment but does not contain the active substance.

The purpose of the study is to evaluate how well ianalumab works in combination with standard-of-care therapy, which is the usual treatment given for lupus nephritis. Participants in the study will receive either ianalumab or a placebo, along with their regular treatment. The study will last for a period of time, during which participants will have regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, researchers will look at various outcomes, such as the stability of kidney function and any side effects that may occur. The goal is to see if ianalumab can help achieve a stable and complete response in kidney function by the end of the study period. Participants will be closely monitored to ensure their safety and to gather important information about the treatment’s effectiveness and tolerability.

1 randomization and initial treatment

Upon joining the study, participants are randomly assigned to receive either the medication ianalumab or a placebo. Both are administered as a subcutaneous injection using a pre-filled syringe.

The initial treatment involves the use of high-dose corticosteroids and mycophenolic acid (MPA) as part of the standard-of-care therapy for lupus nephritis. This treatment should be started before or on the day of randomization.

2 treatment administration

Participants receive the assigned treatment, either ianalumab or placebo, in combination with standard-of-care therapy. The treatment is administered regularly as per the study protocol.

The goal is to achieve a stable complete renal response by Week 72, which involves maintaining kidney function and reducing protein levels in the urine.

3 monitoring and assessments

Throughout the study, participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes measuring the concentration of ianalumab in the blood and checking for any antibodies that may develop against the medication.

Participants are also monitored for any adverse events or changes in vital signs and laboratory measurements.

4 evaluation of treatment response

The primary goal is to evaluate the incidence of stable complete renal response at Week 72. Participants who discontinue treatment before this time or require higher doses of corticosteroids are considered non-responders.

Secondary evaluations include measuring the time to achieve a significant reduction in protein levels in the urine and assessing overall response rates at Week 48.

5 completion of study

The study is expected to conclude by July 2030. Participants will have completed all required assessments and treatments by this time.

Final evaluations will determine the long-term effectiveness and safety of ianalumab in treating lupus nephritis.

Who Can Join the Study?

  • Adult male and female participants aged 18 years or older at the time of screening
  • Weigh at least 35 kg at screening
  • Have a confirmed clinical diagnosis of SLE (Systemic Lupus Erythematosus) according to specific classification criteria
  • Have a positive anti-nuclear antibody (ANA) test result, which is a blood test that helps detect certain autoimmune diseases, with a specific level at screening or a documented positive result in the past
  • Presence of active LN (Lupus Nephritis) at screening that requires starting treatment, shown by meeting these criteria:
    • A kidney biopsy within 6 months before screening showing specific types of kidney inflammation, or a biopsy done during the screening if not done before
    • A urine test showing a certain level of protein in the urine
    • A kidney function test showing a certain level of kidney function
  • Participants can be newly diagnosed or have been treated before, including those who did not respond to previous treatments, as long as they are on or willing to start standard treatment for LN using MPA (Mycophenolic Acid). This includes:
    • Starting treatment with high dose corticosteroids and MPA before or on the day of randomization
    • Stable dosing of anti-malarial treatment before randomization is recommended unless there are reasons not to use it
    • Participants on azathioprine treatment at screening must switch to MPA before randomization
  • Received at least one dose of a specific type of steroid treatment for the current episode of active LN within 60 days before randomization. If unable to take this treatment, they should start on a specific dose of oral steroids
  • Able to provide signed informed consent, which means they understand the study and agree to participate

Who Cannot Join the Study?

  • Patients who have a different kidney condition other than lupus nephritis cannot participate. Lupus nephritis is a kidney inflammation caused by lupus, an autoimmune disease.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent infection or illness that could affect the study results cannot participate.
  • Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.
  • Patients who have received certain medications or treatments that could affect the study results cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Oncopole Claudius Regaud Toulouse France
Hospital Universitario De Navarra Pamplona Spain
CHU Grenoble Alpes La Tronche France
Innomedica OÜ Tallin Estonia

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Centre Hospitalier Universitaire De Poitiers Poitiers France
Universita Cattolica Del Sacro Cuore Rome Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Saint Maria Hospital Bucharest Romania
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Edouard Herriot Lyon France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Hospital Universitario Dr Peset Aleixandre Valencia Spain
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Spitalul Clinic Judetean De Urgenta Bihor Oradea Romania
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Ospedale San Giovanni Bosco Turin Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
East Tallinn Central Hospital Tallin Estonia
University Hospital Olomouc Olomouc Czechia
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Herne Germany
Hospital Universitario De Canarias La Laguna Spain
Szent Margit Korhaz Budapest Hungary
Fundeni Clinical Institute Bucharest Romania
Cyfvrymn Hhvcdvzxgapa Uxvspyczuruco De Vqxq Vigo Spain
Aaaiidtkqk Pdlsxwql Hxvbqlyu Dt Myotlfifk Marseille France
Byrbibyz Uynhmcaiei Hsomytpb Ckldyp Besançon France
Ucakjafslkiclgaxmvmjx Meplngrh Act Munster Germany
Cddt Dz Npfdf Vandoeuvre Les Nancy France
Afznssf Obnmrruczmb Uszjrotpnskln Onafsxpm Rocogsj Foggia Italy
Hwynjgrc Vkoa dxqoddtm 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
Not recruiting
14.07.2022
Estonia Estonia
Not recruiting
14.07.2022
France France
Not recruiting
14.07.2022
Germany Germany
Not recruiting
14.07.2022
Hungary Hungary
Not recruiting
14.07.2022
Italy Italy
Not recruiting
14.07.2022
Lithuania Lithuania
Not recruiting
14.07.2022
Romania Romania
Not recruiting
14.07.2022
Spain Spain
Not recruiting
14.07.2022

Trial locations

Ianalumab is a medication being studied for its effectiveness, safety, and tolerability in treating active lupus nephritis. It is being tested to see if it can help achieve a stable complete renal response in patients when used alongside standard-of-care therapy.

Investigated diseases:

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 can cause the kidneys to become less effective at filtering waste from the blood, which may result in symptoms such as swelling, high blood pressure, and changes in urine. Over time, lupus nephritis can progress, leading to more severe kidney damage if not managed properly. The severity and progression of the disease can vary widely among individuals, with some experiencing mild symptoms and others facing more significant kidney impairment.

Trial ID:
2023-508559-37-00
Protocol code:
CVAY736K12301
NCT ID:
NCT05126277
Trial Phase:
Therapeutic confirmatory (Phase III)

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