Evidence map›Paper›PMID 38765567›Full record

ArticleKidney international reports2024

Focal Segmental Glomerulosclerosis Patient Baseline Characteristics in the Sparsentan Phase 3 DUPLEX Study.

Howard Trachtman, Jai Radhakrishnan, Michelle N Rheault, Charles E Alpers, Jonathan Barratt, Hiddo J L Heerspink, Irene L Noronha, Vlado Perkovic, Brad Rovin, Hernán Trimarchi and 9 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
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 NCT03493685 (A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03493685 phase3completednot on this map

A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS

TypeinterventionalSponsorTravere Therapeutics, Inc.Ran2018 to 2026Enrolled371ConditionsFocal Segmental GlomerulosclerosisArmssparsentan, Irbesartan
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
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

19 authors.

Howard TrachtmanDivision of Nephrology, Department of Pediatrics, University of Michigan, Ann Arbor, Michigan, USA.
Jai RadhakrishnanDivision of Nephrology, Columbia University, New York, New York, USA.
Michelle N RheaultDivision of Pediatric Nephrology, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Charles E AlpersDepartment of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA.
Jonathan BarrattDepartment of Cardiovascular Sciences, University of Leicester General Hospital, Leicester, UK.
Hiddo J L HeerspinkDepartment of Clinical Pharmacy and Pharmacology, University of Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Irene L NoronhaDivision of Nephrology, University of São Paulo School of Medicine, São Paulo, Brazil.
Vlado PerkovicFaculty of Medicine, University of New South Wales Sydney, Sydney, New South Wales, Australia.
Brad RovinDivision of Nephrology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Hernán TrimarchiNephrology Service, Hospital Británico de Buenos Aires, Buenos Aires, Argentina.
Muh Geot WongThe George Institute for Global Health, Sydney, Australia.
Alex MercerJAMCO Pharma Consulting, Stockholm, Sweden.
Jula InrigTravere Therapeutics Inc., San Diego, California, USA.
William RoteTravere Therapeutics Inc., San Diego, California, USA.
Ed MurphyTravere Therapeutics Inc., San Diego, California, USA.
Patricia W BedardTravere Therapeutics Inc., San Diego, California, USA.
Sandra RothTravere Therapeutics Inc., San Diego, California, USA.
Stewart BielerTravere Therapeutics Inc., San Diego, California, USA.
Radko KomersTravere Therapeutics Inc., San Diego, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The phase 3 DUPLEX trial is evaluating sparsentan, a novel, nonimmunosuppressive, single-molecule dual endothelin angiotensin receptor antagonist, in patients with focal segmental glomerulosclerosis (FSGS). Methods: DUPLEX (NCT03493685) is a global, multicenter, randomized, double-blind, parallel-group, active-controlled study evaluating the efficacy and safety of sparsentan 800 mg once daily versus irbesartan 300 mg once daily in patients aged 8 to 75 years (USA/UK) and 18 to 75 years (ex-USA/UK) weighing ≥20 kg with biopsy-proven FSGS or documented genetic mutation in a podocyte protein associated with FSGS, and urine protein-to-creatinine ratio (UP/C) ≥1.5 g/g. Baseline characteristics blinded to treatment allocation are reported descriptively. Results: The primary analysis population includes 371 patients (336 adult, 35 pediatric [<18 years]) who were randomized and received study drug (median age, 42 years). Patients were White (73.0%), Asian (13.2%), Black/African American (6.7%), or Other race (7.0%); and from North America (38.8%), Europe (36.1%), South America (12.7%), or Asia Pacific (12.4%). Baseline median UP/C was 3.0 g/g; 42.6% in nephrotic-range (UP/C >3.5 g/g [adults]; >2.0 g/g [pediatrics]). Patients were evenly distributed across estimated glomerular filtration rate (eGFR) categories corresponding to chronic kidney disease (CKD) stages 1 to 3b. Thirty-three patients (9.4% of 352 evaluable samples) had pathogenic or likely pathogenic (P/LP) variants of genes essential to podocyte structural integrity and function, 27 (7.7%) had P/LP collagen gene ( Conclusions: Patient enrollment in DUPLEX, the largest interventional study in FSGS to date, will enable important characterization of the treatment effect of sparsentan in a geographically broad and clinically diverse FSGS population.

Indexed as

dual endothelin angiotensin receptor antagonistfocal segmental glomerulosclerosispediatricracerandomized controlled clinical trialsparsentan

Identifiers

PMID38765567
PMCPMC11101813

What Socratic 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 Socratic graph.