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

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What is this study about?

This clinical trial is focused on studying a condition called Lupus Nephritis, which is a type of kidney inflammation that occurs in people with lupus, an autoimmune disease. The study is testing a treatment called Obinutuzumab, which is a medication given through an infusion into a vein. The purpose of the study is to evaluate how effective and safe Obinutuzumab is for adolescents with active Class III or IV Lupus Nephritis. Additionally, the study will look at the safety and how the body processes the drug in younger children aged 5 to under 12 years old.

Participants in the study will receive either Obinutuzumab or a placebo. The study will last for about 76 weeks, during which time participants will have regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to see if the treatment can help achieve a complete or partial improvement in kidney function and reduce symptoms of the disease. The study will also track any side effects or changes in health that occur during the treatment period.

In addition to Obinutuzumab, the study involves other medications like Myfenax and CellCept, which contain the active ingredient Mycophenolate Mofetil. These medications are used to suppress the immune system and help manage symptoms of Lupus Nephritis. The study will help determine the best way to use these treatments to improve the health of patients with this condition. Participants will be closely monitored to ensure their safety and to gather important information about how these treatments work in young patients.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a renal biopsy if not performed in the last 12 months.

Eligibility criteria include being aged 12 to under 18, having active Class III or IV lupus nephritis, and a positive test for antinuclear antibodies or antibodies to double-stranded DNA.

2 randomization and baseline measurements

Participants are randomly assigned to receive either obinutuzumab or a placebo. Baseline measurements, including urine protein-to-creatinine ratio and estimated glomerular filtration rate, are recorded.

3 treatment phase

Participants receive obinutuzumab as a 1,000 mg intravenous infusion or a placebo at specified intervals. The treatment phase lasts up to 76 weeks.

In addition to the study drug, participants may receive mycophenolate mofetil in the form of Myfenax 500 mg tablets or CellCept 1 g/5 ml oral suspension, taken orally as prescribed by the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes blood tests, urine tests, and assessments of kidney function.

Participants are evaluated for any side effects or adverse events throughout the study period.

5 completion and final evaluation

At the end of the 76-week treatment period, a final evaluation is conducted to determine the overall response to the treatment.

The primary goal is to assess the proportion of participants achieving a complete renal response, as well as any changes in kidney function and disease activity.

Who Can Join the Study?

Participants must be adolescents aged 12 to less than 18 years old at the time of joining the study, or children aged 5 to less than 12 years old.
Participants must have active Lupus Nephritis (LN), specifically Class III or IV, as shown by a kidney biopsy done in the last 12 months or during the screening period. A biopsy is a test where a small piece of tissue is taken from the body to look for disease.
Participants must have a positive test, either currently or in the past, for antinuclear antibody (ANA) or antibodies to double-stranded DNA (dsDNA). These are specific blood tests that help diagnose certain autoimmune diseases.
Participants can have Class V disease along with Class III or IV LN, but those with only Class V disease cannot join the study.
Participants must have significant proteinuria, which means having a high level of protein in the urine. This is measured by a urine protein-to-creatinine ratio (UPCR) greater than 0.5 g/g, based on a first-morning urine sample during screening.
In the 12 months before or during the screening, all participants must have received at least one dose of pulse-range IV methylprednisolone or an equivalent medication. This is a strong anti-inflammatory drug given through a vein to treat the current episode of active LN.

Who Cannot Join the Study?

Patients who do not have Lupus Nephritis (LN), which is a kidney condition related to lupus, cannot participate.
Patients who are not within the age range of 5 to less than 12 years old are excluded.
Patients who are not part of the vulnerable population selected for the study 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
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Hopital Beaujon	Clichy	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Umiadfivfmssef Cieroxg Kxvzxijse	Gdansk	Poland
Fidbyyjsn Ptab Ly Ilhdetxxpaxfg Bvmlepjqx Dmx Hfsifoal Usqgihgvhdalz Lw Pei	Madrid	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.11.2022
Italy	Recruiting	15.11.2022
Poland	Recruiting	15.11.2022
Spain	Recruiting	15.11.2022

Trial locations

Investigated drugs:

Obinutuzumab is a medication being studied for its effectiveness and safety in treating lupus nephritis, a kidney condition associated with lupus. It is being tested in adolescent patients with active Class III or IV lupus nephritis. The study also includes an evaluation of its safety and how it behaves in the body in a group of younger pediatric patients aged 5 to under 12 years.

Investigated diseases:

Lupus nephritis

Lupus Nephritis – Lupus Nephritis is a kidney disorder that occurs as 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 symptoms such as swelling, high blood pressure, and changes in urine, including blood or protein. Over time, the inflammation can impair kidney function, leading to a decrease in the kidneys’ ability to filter waste from the blood. The progression of Lupus Nephritis can vary, with some individuals experiencing mild symptoms and others facing more severe kidney involvement. Regular monitoring and management are essential to prevent further kidney damage.

Trial ID:

2023-505825-15-00

Protocol code:

WA42985

Trial Phase:

Therapeutic exploratory (Phase II)

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

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