Evidence map›Paper›PMID 38312795›Full record

ArticleKidney international reports2024

Iptacopan in Idiopathic Immune Complex-Mediated Membranoproliferative Glomerulonephritis: Protocol of the APPARENT Multicenter, Randomized Phase 3 Study.

Marina Vivarelli, Andrew S Bomback, Matthias Meier, Yaqin Wang, Nicholas J A Webb, Uday Kiran Veldandi, Richard J H Smith, David Kavanagh

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05755386 (A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
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.

NCT05755386 phase3recruitingnot on this map

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2023 to 2029Enrolled106ConditionsIC-MPGNArmsPlacebo, iptacopan
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Membranoproliferative Glomerulonephritis Pattern of Injury.Advances in kidney disease and health · 2024
    Review
  14. C3G and Ig-MPGN-treatment standard.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024
    Review
  15. 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

8 authors at 6 institutions in 5 countries.

Marina VivarelliDivision of Nephrology, Laboratory of Nephrology, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
Andrew S BombackDivision of Nephrology, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York, USA.
Matthias MeierGlobal Drug Development, Novartis Pharma AG, Basel, Switzerland.
Yaqin WangGlobal Drug Development, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Nicholas J A WebbGlobal Drug Development, Novartis Pharma AG, Basel, Switzerland.
Uday Kiran VeldandiGlobal Drug Development, Novartis HC Pvt Ltd, Hyderabad, India.
Richard J H SmithMolecular Otolaryngology and Renal Research Laboratories and the Departments of Internal Medicine and Pediatrics (Divisions of Nephrology), Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.
David KavanaghNational Renal Complement Therapeutics Centre, Newcastle upon Tyne Hospitals, National Health Service Foundation Trust, Newcastle upon Tyne, UK.
Novartis (Switzerland) · CHBambino Gesù Children's Hospital · ITColumbia University · USNational Health Service · GBNovartis (India) · INUniversity of Iowa · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN) is an ultra-rare, fast-progressing kidney disease that may be idiopathic (primary) or secondary to chronic infection, autoimmune disorders, or monoclonal gammopathies. Dysregulation of the alternative complement pathway is implicated in the pathophysiology of IC-MPGN; and currently, there are no approved targeted treatments. Iptacopan is an oral, highly potent proximal complement inhibitor that specifically binds to factor B and inhibits the alternative pathway (AP). Methods: This randomized, double-blind, placebo-controlled phase 3 study (APPARENT; NCT05755386) will evaluate the efficacy and safety of iptacopan in patients with idiopathic (primary) IC-MPGN, enrolling up to 68 patients (minimum of 10 adolescents) aged 12 to 60 years with biopsy-confirmed IC-MPGN, proteinuria ≥1 g/g, and estimated glomerular filtration rate (eGFR) ≥30 ml/min per 1.73 m Conclusion: This study will provide evidence toward the efficacy and safety of iptacopan in idiopathic (primary) IC-MPGN.

Indexed as

alternative complement pathwayglomerular filtration rateIC-MPGNidiopathic immune complex–mediated membranoproliferative glomerulonephritisiptacopanphase 3 study design

Identifiers

PMID38312795
PMCPMC10831369
OpenAlexW4388009707

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.