Evidence map›Paper›PMID 32274453›Full record

ArticleKidney international reports2020

Study Design of the Phase 3 Sparsentan Versus Irbesartan (DUPLEX) Study in Patients With Focal Segmental Glomerulosclerosis.

Radko Komers, Ulysses Diva, Jula K Inrig, Andrea Loewen, Howard Trachtman, William E Rote

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Kidney international reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 3 pooled it
5.6field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 3 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Interventions for focal segmental glomerulosclerosis in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
  4. Trial
  5. Safety and efficacy of dapagliflozin in patients with focal segmental glomerulosclerosis: a prespecified analysis of the dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
    Trial
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. [Treatment and Prospects of Focal Segmental Glomerulosclerosis].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025
    Review
  12. Article
  13. Endothelin-1 signaling in the kidney: recent advances and remaining gaps.American journal of physiology. Renal physiology · 2025
    Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Endothelin System in Hypertension and Chronic Kidney Disease.Hypertension (Dallas, Tex. : 1979) · 2024
    Review
  20. 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 2 institutions in 1 country.

Radko KomersNephrology, Retrophin, Inc., San Diego, California, USA.
Ulysses DivaBiometrics, Retrophin, Inc., San Diego, California, USA.
Jula K InrigTherapeutic Science and Strategy Unit, IQVIA, Inc., San Diego, California, USA.
Andrea LoewenResearch and Development, Retrophin, Inc., San Diego, California, USA.
Howard TrachtmanDivision of Pediatric Nephrology, New York University School of Medicine, New York, New York, USA.
William E RoteResearch and Development, Retrophin, Inc., San Diego, California, USA.
IQVIA (United States) · USNew York University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFocal segmental glomerulosclerosis (FSGS), a histologic lesion in the kidney caused by varied pathophysiological processes, leads to end-stage kidney disease in a large proportion of patients. Sparsentan is a first-in-class orally active compound combining endothelin type A (ET

methodsDUPLEX is a multicenter, international, phase 3, randomized, double-blind, active-controlled study of sparsentan in patients with FSGS. Approximately 300 patients aged 8 to 75 years, inclusive (United States), and 18 to 75 years, inclusive (outside United States) will be randomized 1:1 to daily treatment with sparsentan or irbesartan. After renin-angiotensin-aldosterone system inhibitor washout, treatment will be administered for 108 weeks, with the final assessment at week 112, four weeks after withdrawal of study drug.

resultsThe primary endpoint will be the slope of estimated glomerular filtration rate from week 6 to week 108. A novel surrogate efficacy endpoint, the proportion of patients achieving urinary protein-to-creatinine (UP/C) ratio of ≤1.5 g/g and >40% reduction from baseline in UP/C (FSGS partial remission endpoint: FPRE), will be evaluated at a planned interim analysis at week 36. Safety and tolerability of sparsentan will also be assessed.

conclusionThe phase 3 DUPLEX study will characterize the long-term antiproteinuric efficacy and nephroprotective potential of dual ET

Indexed as

angiotensin II type 1 receptor blockadeendothelin type A receptor blockadefocal segmental glomerulosclerosisirbesartanproteinuriasparsentan

Identifiers

PMID32274453
PMCPMC7136327
OpenAlexW2999129752

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.