Evidence map›Paper›PMID 30361325›Full record

Trial reportJournal of the American Society of Nephrology : JASN2018

DUET: A Phase 2 Study Evaluating the Efficacy and Safety of Sparsentan in Patients with FSGS.

Howard Trachtman, Peter Nelson, Sharon Adler, Kirk N Campbell, Abanti Chaudhuri, Vimal Kumar Derebail, Giovanni Gambaro, Loreto Gesualdo, Debbie S Gipson, Jonathan Hogan and 11 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01613118 (Efficacy and Safety of Sparsentan), which is not on this map. Cited by 108 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 6 pooled it
10.2field-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.

NCT01613118 phase2completednot on this map

Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study

TypeinterventionalSponsorTravere Therapeutics, Inc.Ran2014 to 2024Enrolled109ConditionsFocal Segmental GlomerulosclerosisArmsRE-021 (Sparsentan), Irbesartan
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 6 syntheses or guidelines pooled it, 181 citations in OpenAlex.

  1. Pooled it
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  5. Interventions for focal segmental glomerulosclerosis in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
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  7. Proteinuria Reduction and Kidney Survival in Focal Segmental Glomerulosclerosis.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2021
    Trial
  8. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2020
    Trial
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48 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 18 institutions in 3 countries.

Howard TrachtmanDivision of Pediatric Nephrology, Department of Pediatrics, New York University School of Medicine, Langone Medical Center, New York, New York; howard.trachtman@nyumc.org radko.komers@retrophin.com.
Peter NelsonDivision of Nephrology and Kidney Research Institute, University of Washington, Seattle, Washington.
Sharon AdlerDivision of Nephrology and Hypertension, Los Angeles Biomedical Research Institute at Harbor-University of California, Los Angeles Medical Center, Torrance, California.
Kirk N CampbellDivision of Nephrology, Icahn School of Medicine at Mount Sinai, New York, New York.
Abanti ChaudhuriDivision of Pediatric Nephrology, Stanford University, Palo Alto, California.
Vimal Kumar DerebailDivision of Nephrology and Hypertension, University of North Carolina Kidney Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Giovanni GambaroDivision of Nephrology and Dialysis, Università Cattolica del Sacro Cuore, Fondazione Policlinico A. Gemelli, Rome, Italy.
Loreto GesualdoNephrology Unit, Department of Emergency and Organ Transplantation (DETO), Azienda Ospedaliero Universitaria Policlinico di Bari, Bari, Italy.
Debbie S GipsonDivision of Pediatric Nephrology, University of Michigan, Ann Arbor, Michigan.
Jonathan HoganDepartment of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Kenneth LiebermanDepartment of Pediatric Nephrology, Joseph M. Sanzari Children's Hospital, Hackensack University Medical Center, Hackensack, New Jersey.
Brad MarderDivision of Transplant Research, Colorado Kidney Care, Denver, Colorado.
Kevin Edward MeyersDivision of Nephrology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Esmat MustafaDepartment of Nephrology and Research Division, Arizona Kidney Disease and Hypertension Center, Phoenix, Arizona.
Jai RadhakrishnanDivision of Nephrology, Columbia University, New York, New York.
Tarak SrivastavaChildren's Mercy Hospital, Kansas City, Missouri.
Miganush StepaniansPROMETRIKA, LLC., Cambridge, Massachusetts.
Vladimír TesarDepartment of Nephrology, Charles University, Prague, Czech Republic.
Olga ZhdanovaDivision of Nephrology, New York University School of Medicine, New York, New York; and.
Radko KomersDepartment of Research & Development, Retrophin, Inc., San Diego, California howard.trachtman@nyumc.org radko.komers@retrophin.com.
DUET Study Group
Colorado Kidney Care · USAzienda Universitaria Ospedaliera Consorziale - Policlinico Bari · ITChildren's Hospital of Philadelphia · USChildren's Mercy Hospital · USColumbia University · USGeneral University Hospital in Prague · CZHackensack University Medical Center · USIcahn School of Medicine at Mount Sinai · USLos Angeles Medical Center · USNew York University · USNYU Langone Health · USPromega (United States) · USStanford University · USUniversità Cattolica del Sacro Cuore · ITUniversity of Michigan–Ann Arbor · USUniversity of North Carolina at Chapel Hill · USUniversity of Pennsylvania · USUniversity of Washington · US

Funding

Project-005UL1TR001445 · NCATS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BREDELLA, MIRIAM ANTOINETTE, HOCHMAN, JUDITH S · 2015 to 2025
$103.5M
NCATS NIH HHS UL1 TR001445
6 · The paper itself

Abstract

backgroundWe evaluated and compared the effects of sparsentan, a dual endothelin type A (ET

methodsIn this phase 2, randomized, double-blind, active-control Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients with Focal Segmental Glomerulosclerosis (FSGS): A Randomized, Double-blind, Active-Control, Dose-Escalation Study (DUET), patients aged 8-75 years with biopsy-proven FSGS, eGFR>30 ml/min per 1.73 m

resultsOf 109 patients randomized, 96 received study drugs and had baseline and week 8 UP/C measurements. Sparsentan-treated patients had greater reductions in UP/C than irbesartan-treated patients did when all doses (45% versus 19%;

conclusionsPatients with FSGS achieved significantly greater reductions in proteinuria after 8 weeks of sparsentan versus irbesartan. Sparsentan was safe and well tolerated.

Indexed as

AdolescentAdultAgedAngiotensin II Type 1 Receptor BlockersChildCreatinineDose-Response Relationship, DrugDouble-Blind MethodEndothelin A Receptor AntagonistsFemaleGlomerulosclerosis, Focal SegmentalHumansIrbesartanMaleMiddle AgedProteinuriaAngiotensin II Type 1 Receptor BlockersCreatinineEndothelin A Receptor AntagonistsIrbesartansparsentanSpiro CompoundsSulfonamidesangiotensin IIendothelinfocal segmental glomerulosclerosisproteinuriasparsentan

Identifiers

PMID30361325
PMCPMC6218860
OpenAlexW2898491544

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.