Evidence map›Paper›PMID 26758039›Full record

Trial reportClinical and experimental nephrology2016

Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial.

Kosuke Masutani, Akihiro Tsuchimoto, Tomomi Yamada, Makoto Hirakawa, Koji Mitsuiki, Ritsuko Katafuchi, Hideki Hirakata, Takanari Kitazono, Kazuhiko Tsuruya, West Japan Study Group for Therapy of IgA Nephropathy Investigators

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical and experimental nephrology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
–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.

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

7 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Immunosuppressive agents for treating IgA nephropathy.The Cochrane database of systematic reviews · 2020
    Pooled it
  4. Review
  5. Inflammation in IgA nephropathy.Pediatric nephrology (Berlin, Germany) · 2017
    Review
  6. Article
  7. 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

10 authors.

Kosuke MasutaniDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Akihiro TsuchimotoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tomomi YamadaDepartment of Clinical Epidemiology and Biostatistics, Graduate School of Medicine, Osaka University, Suita, Japan.
Makoto HirakawaDivision of Nephrology, Harasanshin Hospital, Fukuoka, Japan.
Koji MitsuikiNephrology and Dialysis Center, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan.
Ritsuko KatafuchiKidney Unit, National Fukuoka-Higashi Medical Center, Koga, Japan.
Hideki HirakataNephrology and Dialysis Center, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan.
Takanari KitazonoDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Kazuhiko TsuruyaDepartment of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. tsuruya@intmed2.med.kyushu-u.ac.jp.
West Japan Study Group for Therapy of IgA Nephropathy Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe significance of immunosuppressants as an adjunct treatment with corticosteroids for IgA nephropathy (IgAN) has not been well demonstrated. This study was performed to compare two treatment regimens, steroid-pulse therapy or combined with mizoribine (MZR) in progressive IgAN.

methodsStudy design was a prospective randomized controlled trial of 40 patients with moderate to severe glomerular injuries who were randomly administered either pulse methylprednisolone followed by a 25-month course of oral prednisolone (P group, n = 20) or in combination with MZR (150 mg/day for 24 months, M + P group, n = 20). The primary endpoint was a reduction of proteinuria by ≥50 % of the baseline value. Secondary endpoints were increased serum creatinine (Cr) by ≥50 %, or a decrease in estimated glomerular filtration rate by ≤50 %.

resultsTwenty-five months after the initiation of treatment, urinary protein excretion significantly declined from the median of 0.98 to 0.17 g/gCr in the P group (P < 0.05) and from 1.01 to 0.38 g/gCr in the M + P group (P < 0.05). There was no statistical difference in the serial changes of proteinuria between two groups (P = 0.81). All patients reached the primary endpoint, and the cumulative incidence of the reduction of proteinuria was not significantly different (P = 0.76). No patient reached the secondary endpoint during the 25 months of treatment.

conclusionsBoth therapeutic regimens significantly reduced the levels of proteinuria. We could not find the additional effect of MZR in combination with steroid-pulses in this small-scale controlled trial. Steroid-pulse therapy with a 25-month course of oral steroids seems to be effective for progressive IgAN.

Indexed as

AdultBlood PressureFemaleGlomerular Filtration RateGlomerulonephritis, IGAHumansMaleMethylprednisoloneMiddle AgedProspective StudiesProteinuriaRibonucleosidesMethylprednisolonemizoribineRibonucleosidesAntimetaboliteMethylprednisoloneOxford classificationProteinuriaRenin-angiotensin system (RAS) inhibitor

Identifiers

What OpenQuestion holds

Textmetadata
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Registered trials

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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.