Evidence map›Paper›PMID 40993587›Full record

Trial reportBMC pediatrics2025

Combined impact of rituximab and target care on efficacy, quality of life, adverse reactions and recurrence rate in children with nephrotic syndrome: a randomized controlled trial.

Lanfen He, Huazhen Mei, Yan Gu, Zeng Liu, Lian Yang, Xiaolu Li, Xiaofeng Wang, Ting Xu

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07049172 (Efficacy and Safety of Rituximab in Reducing Relapses in Children With Steroid-Sensitive Nephrotic Syndrome), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07049172 nacompletednot on this map

Efficacy and Safety of Rituximab in Reducing Relapses in Children With Steroid-Sensitive Nephrotic Syndrome: An Open-label, Multi-center Clinical Study.

TypeinterventionalSponsorWuhan Children's HospitalRan2021 to 2023Enrolled91ConditionsNephrotic Syndrome in ChildrenArmsRituximab, Targeted Nursing Care, Baseline Glucocorticoid Therapy, Tacrolimus
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Lanfen He *Department of Nephrology, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Center), Tongji Medical College, Huazhong University of Science & Technology, No. 100, Hong Kong Road, Jiangan District, Wuhan, Hubei, China.
Huazhen Mei *Department of Nephrology, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Center), Tongji Medical College, Huazhong University of Science & Technology, No. 100, Hong Kong Road, Jiangan District, Wuhan, Hubei, China.
Yan GuDepartment of Nephrology, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Center), Tongji Medical College, Huazhong University of Science & Technology, No. 100, Hong Kong Road, Jiangan District, Wuhan, Hubei, China.
Zeng LiuDepartment of Nephrology, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Center), Tongji Medical College, Huazhong University of Science & Technology, No. 100, Hong Kong Road, Jiangan District, Wuhan, Hubei, China.
Lian YangDepartment of Nephrology, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Center), Tongji Medical College, Huazhong University of Science & Technology, No. 100, Hong Kong Road, Jiangan District, Wuhan, Hubei, China.
Xiaolu LiDepartment of Nephrology, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Center), Tongji Medical College, Huazhong University of Science & Technology, No. 100, Hong Kong Road, Jiangan District, Wuhan, Hubei, China.
Xiaofeng WangDepartment of Nephrology, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Center), Tongji Medical College, Huazhong University of Science & Technology, No. 100, Hong Kong Road, Jiangan District, Wuhan, Hubei, China. 453368882@qq.com.
Ting XuInternational Medical Department, Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Center), Tongji Medical College, Huazhong University of Science & Technology, No. 100, Hong Kong Road, Jiangan District, Wuhan, Hubei, China. 14771929@qq.com.

Funding

Wuhan Medical Research Project in 2019 WX19Q09
6 · The paper itself

Abstract

backgroundThe present study was conducted as a randomized controlled trial to investigate the combined impact of rituximab and target care on efficacy, quality of life, adverse reactions, and recurrence rate among children with nephrotic syndrome.

methodsThis was a prospective, randomized, open-label, controlled trial conducted at a single tertiary children's hospital. Ninety-one pediatric patients with nephrotic syndrome were enrolled between January 2021 and June 2023. Patients were randomly assigned (1:1) to the study group (receiving initial corticosteroid therapy followed by rituximab combined with target care, n = 46) or the control group (receiving initial corticosteroid therapy followed by oral tacrolimus capsules combined with target care, n = 45). The primary outcome was clinical efficacy at 3 months. Secondary outcomes included quality of life (IS-LQ questionnaire at baseline and 3 months), adverse reactions, 6-month recurrence rate, and CD19 + B-cell counts (study group only). Analysis was by intention-to-treat.

resultsOf 115 children assessed for eligibility, 91 were randomized. All randomized patients completed the 3-month efficacy assessment and were included in the analysis. After treatment, the study group was associated with significantly better efficacy (45/46, 97.83%) than that of the control group (38/45, 84.44%) (Risk Difference 13.39%, 95% CI 1.63-25.15%; P = 0.029). After treatment, the quality of life in both groups was significantly improved (P < 0.001 compared to baseline for each group). The quality of life in the study group was slightly increased as compared to the control group, but the difference was not statistically significant (P > 0.05). All patients in the study group achieved adequate B-cell depletion. The recurrence rate at 6 months in the study group (18/46, 39.13%) was lower as compared to the control group (30/45, 66.67%) (Risk Difference - 27.54%, 95% CI - 47.00% to - 8.08%; P = 0.009). The incidence of adverse reactions, including mild transient neutropenia, was comparable between the two groups (P > 0.05).

conclusionThe rituximab-based regimen combined with target care exhibited beneficial outcomes by effectively improving clinical efficacy and reducing recurrence for children with nephrotic syndrome, with a safety profile comparable to a tacrolimus-based regimen over the study period. Quality of life improved in both groups. Further studies with longer follow-up are needed to assess long-term outcomes and safety.

trial registrationClinicalTrials.gov, NCT07049172.

Indexed as

Immunologic FactorsImmunosuppressive AgentsNephrotic SyndromeQuality of LifeRituximabTacrolimusAdolescentAdrenal Cortex HormonesChildChild, PreschoolDrug Therapy, CombinationFemaleHumansMaleProspective StudiesRecurrenceAdrenal Cortex HormonesImmunologic FactorsImmunosuppressive AgentsRituximabTacrolimusNephrotic syndromeQuality of lifeRandomized controlled trialRituximabTarget care

Identifiers

PMID40993587
PMCPMC12462134

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.