Evidence map›Paper›PMID 40100934›Full record

ArticlePloS one2025

Randomised, double-blind study to evaluate the efficacy of rituximab in the treatment of idiopathic membranous nephropathy: A clinical trial protocol.

Shinobu Shimizu, Akihito Tanaka, Nao Matsuyama, Fumie Kinoshita, Kazuhiro Furuhashi, Shoichi Maruyama, PRIME Study Group

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05914155 (The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05914155 phase3active not recruitingnot on this map

The Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rituximab (Genetical Recombination) for the Treatment for Idiopathic Membranous Nephropathy With Nephrotic Syndrome (PRIME Study)

TypeinterventionalSponsorShoichi Maruyama MD PhDRan2023 to 2028Enrolled88ConditionsGlomerulonephritis, Membranous, Nephrotic Syndrome,IdiopathicArmsRituximab (genetical recombination), Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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

7 authors.

Shinobu ShimizuDepartment of Advanced Medicine, Nagoya University Hospital, Nagoya, Aichi, Japan.ORCID https://orcid.org/0000-0001-9066-3489
Akihito TanakaDepartment of Nephrology, Nagoya University Hospital, Nagoya, Aichi, Japan.ORCID https://orcid.org/0000-0001-8866-5901
Nao MatsuyamaDepartment of Advanced Medicine, Nagoya University Hospital, Nagoya, Aichi, Japan.
Fumie KinoshitaDepartment of Advanced Medicine, Nagoya University Hospital, Nagoya, Aichi, Japan.
Kazuhiro FuruhashiDepartment of Nephrology, Nagoya University Hospital, Nagoya, Aichi, Japan.
Shoichi MaruyamaDepartment of Nephrology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan.ORCID https://orcid.org/0000-0002-8858-632X
PRIME Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In Japan, corticosteroid monotherapy has traditionally been recommended as the first-line therapy for membranous nephropathy with nephrotic syndrome. In contrast, except for Japan, rituximab is recommended as the first-line therapy for membranous nephropathy with nephrotic syndrome. This clinical trial aimed to verify the efficacy and safety of the intravenous administration of rituximab without steroids or immunosuppressants as an induction therapy in Japanese patients with idiopathic membranous nephropathy and nephrotic syndrome. This was a multicentre (15 in Japan), placebo-controlled, randomized, double-blind, parallel-group comparative study. A total of 88 patients diagnosed with idiopathic membranous nephropathy and nephrotic syndrome were randomly allocated to rituximab and placebo groups in a 1:1 ratio; rituximab 1,000 mg or placebo IV infusion was administered every 2 weeks for two doses in a double-blinded manner. The primary endpoint was the percentage of patients achieving less than 1.0 g/g creatinine in urine protein/creatinine ratio in random urine at 26 weeks after the first administration of rituximab or placebo. This study was approved by the institutional review boards and conducted in accordance with the Good Clinical Practice guidelines. This study was registered at ClinicalTrials.gov, NCT05914155 and the Japan Registry of Clinical Trials, jRCT2041230037 on 13 June 2023.

Indexed as

Glomerulonephritis, MembranousNephrotic SyndromeRituximabAdultAgedDouble-Blind MethodFemaleHumansJapanMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeRituximab

Identifiers

PMID40100934
PMCPMC11918375

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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.