Evidence map›Paper›PMID 27942609›Full record

ArticleKidney international reports2016

Membranous nephropathy: Pilot study of a novel regimen combining cyclosporine and Rituximab.

Meryl Waldman, Laurence H Beck, Michelle Braun, Kenneth Wilkins, James E Balow, Howard A Austin

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Kidney international reports, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04743739 (A Multicenter Randomized Controlled Trial of Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of Idiopathic Membranous Nephropathy), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 14% 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.

NCT04743739 phase3terminatednot on this mapstarted 2021, after this paper: background citation

A Multicenter Randomized Controlled Trial of Rituximab Combined With Cyclosporine Versus Rituximab Alone in the Treatment of Idiopathic Membranous Nephropathy

TypeinterventionalSponsorPeking Union Medical College HospitalRan2021 to 2024Enrolled12ConditionsIdiopathic Membranous NephropathyArmsRituximab, cyclosporine
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Observational
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Novel Treatments Paradigms: Membranous Nephropathy.Kidney international reports · 2023
    Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Rituximab Dosing in Glomerular Diseases: A Scoping Review.Canadian journal of kidney health and disease · 2022
    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

6 authors at 3 institutions in 1 country.

Meryl WaldmanKidney Disease Section, Kidney Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, Bethesda, MD (NIH).
Laurence H BeckDepartment of Medicine, Section of Nephrology, Boston University School of Medicine, Boston, MA.
Michelle BraunKidney Disease Section, Kidney Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, Bethesda, MD (NIH).
Kenneth WilkinsBiostatistics Program, Office of Director, NIDDK NIH.
James E BalowKidney Disease Section, Kidney Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, Bethesda, MD (NIH).
Howard A AustinKidney Disease Section, Kidney Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health, Bethesda, MD (NIH).
National Institutes of Health · USBoston University · USNational Institute of Diabetes and Digestive and Kidney Diseases · US

Funding

Redefining membranous nephropathy by autoantibody-specific subclassificationR01DK097053 · NIDDK · BOSTON MEDICAL CENTER · PI BECK, LAURENCE H · 2013 to 2017
$1.7M
Intramural NIH HHS Z99 DK999999NIDDK NIH HHS R01 DK097053
6 · The paper itself

Abstract

introductionThere is broad consensus that high grade basal proteinuria and failure to achieve remission of proteinuria are key determinants of adverse renal prognosis in patients with primary membranous nephropathy. Based on the fact that current regimens are not ideal due to short and long-term toxicity and propensity to relapse after treatment withdrawal, we developed a treatment protocol based on a novel combination of rituximab and cyclosporine which targets both the B and T cell limbs of the immune system. Herein, we report pilot study data on proteinuria, changes in autoantibody levels and renal function that offer a potentially effective new approach to treatment of severe membranous nephropathy.

methodsThirteen high-risk patients defined by sustained high-grade proteinuria (mean 10.8 g/d) received combination induction therapy with rituximab plus cyclosporine for 6 months, followed by a second cycle of rituximab and tapering of cyclosporine during an 18 month maintenance phase.

resultsMean proteinuria decreased by 65% at 3 months and by 80% at 6 months. Combined complete or partial remission was achieved in 92% of patients by 9 months; 54% achieved complete remission at 12 months. Two patients relapsed during the trial. All patients with autoantibodies to PLA DISCUSSION: We report these encouraging preliminary results for their potential value to other investigators needing prospectively collected data to inform the design and power calculations of future randomized clinical trials. Such trials will be needed to formally compare this novel regimen to current therapies for membranous nephropathy.

Indexed as

cyclosporineMembranous nephropathynephrotic syndromerituximab

Identifiers

PMID27942609
PMCPMC5138549
OpenAlexW2429519160

What OpenQuestion holds

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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.