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New hope for kids with kidney disease: rituximab cuts relapse risk

NCT ID NCT07049172

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether rituximab, a medication that targets certain immune cells, could help children with a challenging form of nephrotic syndrome (a kidney disease) that keeps coming back. 91 children were split into two groups: one received rituximab plus special nursing care, the other received a standard drug (tacrolimus) plus the same care. The goal was to see which approach better prevented relapses and improved quality of life over 6 months.

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

91 people

The number who actually took part.

Started

Jan 2021

Finished

Dec 2023

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

6 to 15 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: * Diagnosis of primary pediatric nephrotic syndrome, specifically steroid-dependent nephrotic syndrome (SDNS) or frequently relapsing nephrotic syndrome (FRNS), as defined by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. (SDNS is defined as relapse occurring during tapering of glucocorticoids or within 14 days of discontinuation; FRNS is defined as ≥2 relapses within 6 months of initial response or ≥4 relapses in any 12-month period). * Age between 6 and 15 years. * Normal intellectual development and the ability to understand and communicate. * Informed consent obtained from the guardians and assent from children capable of understanding. Exclusion Criteria: * Steroid-resistant nephrotic syndrome (SRNS). * Severe renal insufficiency (according to KDIGO criteria or other relevant standards). * Cognitive or mental disorders. * Worsening condition upon admission necessitating intensive care. * Parents unable to provide long-term care or unwilling to participate. * Interruption of hospitalization for any reason. * Prior treatment with rituximab or tacrolimus. * Co-existing significant kidney, urinary system diseases (other than NS), or severe active urinary tract infection. * Significant liver function impairment. * Known hypersensitivity to rituximab or tacrolimus.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Wuhan Children's Hospital

    Wuhan, Hubei, 430015, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.