Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome (NCT07049172) | Clinical Trial Compass
CompletedNot Applicable
Rituximab and Targeted Nursing for Pediatric Nephrotic Syndrome
China91 participantsStarted 2021-01-01
Plain-language summary
This study investigated the combined impact of rituximab and targeted nursing care versus tacrolimus and targeted nursing care on efficacy, quality of life, adverse reactions, and recurrence rate in children with challenging (steroid-dependent or frequently relapsing) nephrotic syndrome. Ninety-one pediatric patients were randomized to either receive rituximab plus targeted nursing or tacrolimus plus targeted nursing, and outcomes were assessed over a 6-month period.
Who can participate
Age range
6 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Effective Rate
Timeframe: At 6 months post-treatment initiation.
2
Recurrence Rate
Timeframe: Within the 6-month follow-up period after treatment initiation.