Evidence map›Paper›PMID 38106570›Full record

ArticleKidney international reports2023

Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

Edwin Wong, Carla Nester, Teresa Cavero, Alexandre Karras, Moglie Le Quintrec, Liz Lightstone, Ute Eisenberger, Maria Jose Soler, David Kavanagh, Erica Daina and 12 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03832114 (An Open-label, Non-randomized Study on Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LNP023 in Two Patient Populations With C3 Glomerulopathy), which is not on this map. Cited by 70 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 2 pooled it
14.3field-weighted citation impact, top 1% 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.

NCT03832114 phase2completednot on this map

An Open-label, Non-randomized Study on Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LNP023 in Two Patient Populations With C3 Glomerulopathy

TypeinterventionalSponsorNovartis PharmaceuticalsRan2019 to 2021Enrolled27ConditionsGlomerulonephritisArmsLNP023
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 2 syntheses or guidelines pooled it, 87 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Time to move to a cluster-based management of C3G/IC-MPGN.Pediatric nephrology (Berlin, Germany) · 2026
    Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Complement activation in kidney transplantation.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
    Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. Review

10 more citing papers are in PubMed but not listed here.

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

22 authors at 14 institutions in 8 countries.

Edwin WongNational Renal Complement Therapeutics Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
Carla NesterThe University of Iowa Stead Family Children's Hospital, Iowa City, Iowa, USA.
Teresa CaveroNephrology Department, University Hospital Doce de Octubre, Madrid, Spain.
Alexandre KarrasDepartment of Nephrology, Hôpital Européen Georges-Pompidou, APHP, Paris, France.
Moglie Le QuintrecService de Néphrologie et Transplantation Rénale, Centre Hospitalier Universitaire de Montpellier, Montpellier, France.
Liz LightstoneCentre for Inflammatory Disease, Department of Immunology and Inflammation, Imperial College London, London, UK.
Ute EisenbergerDepartment of Nephrology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Maria Jose SolerNephrology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Research, CSUR National Unit of Expertise for Complex Glomerular Diseases of Spain, Barcelona, Spain.
David KavanaghNational Renal Complement Therapeutics Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
Erica DainaIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Manuel PragaInstituto de Investigación Hospital 12 de Octubre (i+12), Madrid, Spain.
Nicholas R Medjeral-ThomasCentre for Inflammatory Disease, Department of Immunology and Inflammation, Imperial College London, London, UK.
Anja GäcklerDepartment of Nephrology, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Clara Garcia-CarroNephrology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Research, CSUR National Unit of Expertise for Complex Glomerular Diseases of Spain, Barcelona, Spain.
Andrea BiondaniNovartis Institutes for BioMedical Research, Translational Medicine, Novartis AG, Basel, Switzerland.
Frederique ChaperonNovartis Institutes for BioMedical Research, Translational Medicine, Novartis AG, Basel, Switzerland.
Kenneth KulmatyckiNovartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.
Julie MilojevicNovartis Institutes for BioMedical Research, Translational Medicine, Novartis AG, Basel, Switzerland.
Nicholas J A WebbNovartis Institutes for BioMedical Research, Translational Medicine, Novartis AG, Basel, Switzerland.
Prasanna Kumar NidamarthyNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Guido JungeNovartis Institutes for BioMedical Research, Translational Medicine, Novartis AG, Basel, Switzerland.
Giuseppe RemuzziIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
Novartis Institutes for BioMedical ResearchImperial College London · GBMario Negri Institute for Pharmacological Research · ITNovartis (Switzerland) · CHUniversity of Duisburg-Essen · DEVall d'Hebron Hospital Universitari · ESCentre Hospitalier Universitaire de Montpellier · FRHôpital Européen · FRNewcastle University · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBNovartis (India) · INNovartis (United States) · USResearch Institute Hospital 12 de Octubre · ESUniversity of Iowa Stead Family Children’s Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Complement 3 glomerulopathy (C3G) is a rare inflammatory kidney disease mediated by dysregulation of the alternative complement pathway. No targeted therapy exists for this aggressive glomerulonephritis. Efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) (measured by complement biomarkers) of iptacopan were assessed in patients with C3G. Methods: In this phase 2, multicenter, open-label, single-arm, nonrandomized study, adults with biopsy-proven, native kidney C3G (native cohort) and kidney transplant recipients with C3G recurrence (recurrent kidney transplant [KT] cohort) received iptacopan twice daily (bid) for 84 days (days 1-21: 10-100 mg; days 22-84: 200 mg). The primary end point was the urine protein-to-creatinine ratio (UPCR; native cohort) and the change in the C3 deposit score of kidney biopsy (recurrent KT cohort). The complement pathway measures included Wieslab assay, soluble C5b9, and serum C3 levels. Results: A total of 27 patients (16 native cohort and 11 recurrent KT cohort) were enrolled and all completed the study. In the native cohort, UPCR levels decreased by 45% from baseline to week 12 ( Conclusion: Iptacopan resulted in statistically significant and clinically important reductions in UPCR and normalization of serum C3 levels in the native cohort and reduced C3 deposit scores in the recurrent KT cohort with favorable safety and tolerability. (ClinicalTrials.gov identifier: NCT03832114).

Indexed as

complement 3 glomerulopathyinflammatory kidney diseaseiptacopankidney transplanturine protein-to-creatinine ratio

Identifiers

PMID38106570
PMCPMC10719607
OpenAlexW4386964882

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.