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New drug combo aims to tame lupus kidney disease in kids

NCT ID NCT07675291

Disease control Sponsor: Nanfang Hospital, Southern Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether combining rituximab with a low dose of mycophenolate mofetil can safely and effectively treat lupus nephritis in children. Lupus nephritis is a serious kidney complication of lupus. The trial enrolls children aged 3 to 18 with active kidney inflammation. Participants receive the drug combination for six months, and researchers track how well the kidneys respond and whether side effects occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rituximab and mycophenolate mofetil
What this could lead to
If successful, this combination could offer a more effective and safer way to control lupus-related kidney disease in children, reducing the need for stronger drugs.
What could go wrong
This is a relatively small, early-stage study, so results may not apply to all children. The combination carries risks like infection and immune suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 112 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Children aged 3-18 years old, regardless of sex; 2. SLE patients who meet the 2019 EULAR/ACR SLE criteria or the 2012 SLICC diagnostic criteria; 3. Diagnosed as lupus nephritis and the classification was consistent with proliferative lupus nephritis (type III or IV, with or without type V); 4. White blood cell count ≥3.0×10\^9/L, and lymphocyte count ≥ 0.5× 10\^9/L and CD20 (or CD19)≥1/ul; 5. No cyclophosphamide or rituximab induction therapy was used before enrollment; 6. Informed consent form is signed by the guardian and children over 8 years old; 7. In the active stage of the disease, the 24-hour urine protein quantification ≥25mg/kg, or the urine protein/creatinine ≥1.0mg/mg; 8. Estimated GFR≥60ml/min/1.73m\^2 (improved Swchartz formula). Exclusion Criteria: 1. Patients with lupus encephalopathy; 2. Estimated GFR\<60ml/min/1.73m\^2(Swchartz formula); 3. HBV-antigen positive, HCV or HIV antibody positive; 4. Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis; 5. Allergic to the active ingredients or any auxiliary materials in rituximab, mycophenolate mofetil or cyclophosphamide; 6. Severe heart failure and liver function damage; 7. Patients who is not suitable to participate in this study judged by the researchers.

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Conditions

The condition(s) this trial relates to.

lupus nephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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