Evidence map›Paper›PMID 30431588›Full record

Trial reportMedicine2018

Efficacy and safety of rituximab in childhood-onset, difficult-to-treat nephrotic syndrome: A multicenter open-label trial in Korea.

Yo Han Ahn, Seong Heon Kim, Kyoung Hee Han, Hyun Jin Choi, Heeyeon Cho, Jung Won Lee, Jae Il Shin, Min Hyun Cho, Joo Hoon Lee, Young Seo Park and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 7 pooled it
3.2field-weighted citation impact, top 8% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 7 syntheses or guidelines pooled it, 59 citations in OpenAlex.

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  8. Steroid-sparing drugs in children and young adults with nephrotic syndrome: a target trial emulation.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
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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

15 authors at 9 institutions in 1 country.

Yo Han AhnDepartment of Pediatrics, Seoul National University Bundang Hospital, Seongnam.
Seong Heon KimDepartment of Pediatrics, Pusan National University Children's Hospital, Yangsan.
Kyoung Hee HanDepartment of Pediatrics, Jeju National University School of Medicine, Jeju.
Hyun Jin ChoiDepartment of Pediatrics, Seoul National University Children's Hospital, Seoul.
Heeyeon ChoDepartment of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.
Jung Won LeeDepartment of Pediatrics, Ewha Womans University School of Medicine, Seoul.
Jae Il ShinDepartment of Pediatrics, Yonsei University College of Medicine, Severance Children's Hospital, Seoul.
Min Hyun ChoDepartment of Pediatrics, Kyungpook National University, School of Medicine, Daegu.
Joo Hoon LeeDepartment of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Korea.
Young Seo ParkDepartment of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Korea.
Il-Soo HaDepartment of Pediatrics, Seoul National University Children's Hospital, Seoul.
Hae Il CheongDepartment of Pediatrics, Seoul National University Children's Hospital, Seoul.
Su Young KimDepartment of Pediatrics, Pusan National University Children's Hospital, Yangsan.
Seung Joo LeeDepartment of Pediatrics, Ewha Womans University School of Medicine, Seoul.
Hee Gyung KangDepartment of Pediatrics, Seoul National University Children's Hospital, Seoul.
Seoul National University Children's Hospital · KREwha Womans University · KRPusan National University Yangsan Hospital · KRUlsan College · KRJeju National University · KRKyungpook National University · KRSamsung Medical Center · KRSeoul National University Bundang Hospital · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe anti-CD20 monoclonal antibody rituximab (RTX) has been proposed as a rescue therapy for difficult-to-treat nephrotic syndrome (NS). We conducted a clinical trial to evaluate the efficacy and safety of RTX in children with difficult-to-treat NS dependent on or resistant to steroids and calcineurin inhibitors (CNIs).

methodsA multicenter open-label trial was performed at 8 major pediatric nephrology centers in Korea. The investigation consisted of a randomized controlled trial for steroid- and CNI-dependent NS (DDNS; randomization into the RTX group and the control group, at a ratio of 2:1) and a single-arm study of steroid and CNI-resistant NS (DRNS). DDNS patients in the RTX group and DRNS patients received a single dose of intravenous RTX (375 mg/m of body surface area) for B-cell depletion. A second RTX dose was administered at week 2 if the first dose failed to achieve depletion of CD19(+) cells. The primary endpoint was rate of maintaining remission at 6 months after treatment for DDNS and rate of remission achievement for DRNS.

resultsSixty-one children with DDNS were enrolled while in remission and randomized to the control group (21 patients) or the RTX group (40 patients). At 6 months after treatment, the remission rates were 74.3% in the RTX group and 31.3% in the control group (P = .003). The mean duration of remission maintenance was significantly higher in the RTX group than in the control group (9.0 vs 2.9 months, P = .004). Of the 23 patients with DRNS enrolled in the single-arm study and treated with RTX, 9 (39.1%) achieved partial or complete remission within 6 months. Depletion of B cells occurred in all patients with RTX therapy. Thirty patients (50.8% of 59 patients analyzed) experienced mild and transient infusion reaction during RTX administration, and most adverse events were mild.

conclusionsRTX administration was safe and effective in patients with difficult-to-treat NS. One or 2 doses of RTX may be sufficient to deplete B cells and achieve better control of pediatric NS.

Indexed as

AdolescentCalcineurin InhibitorsChildChild, PreschoolFemaleGlucocorticoidsHumansImmunologic FactorsMaleNephrotic SyndromeRemission InductionRepublic of KoreaRituximabTreatment OutcomeCalcineurin InhibitorsGlucocorticoidsImmunologic FactorsRituximab

Identifiers

PMID30431588
PMCPMC6257685
OpenAlexW2901137928

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.