Evidence map›Paper›PMID 34169203›Full record

ArticleKidney international reports2021

PODO: Trial Design: Phase 2 Study of PF-06730512 in Focal Segmental Glomerulosclerosis.

Laurence H Beck, Stephen P Berasi, J Brian Copley, Donal Gorman, Daniel I Levy, Chay Ngee Lim, Joel M Henderson, David J Salant, Weining Lu

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03448692 (A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

NCT03448692 phase2terminatednot on this map

A phase 2, 24-week, adaptive, open label, sequential cohort trial to evaluate the efficacy, safety, tolerability and pharmacokinetics of pf-06730512 following multiple doses in adult subjects with focal segmental glomerulosclerosis (fsgs)

TypeinterventionalSponsorPfizerRan2018 to 2023Enrolled47ConditionsFocal Segmental Glomerulosclerosis (FSGS)ArmsPF-06730512
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Article
  3. SLIT2 as a key regulator and therapeutic target in liver injury.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Precision medicine for focal segmental glomerulosclerosis.Kidney research and clinical practice · 2024
    Article
  10. Review
  11. Review
  12. 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

9 authors at 3 institutions in 2 countries.

Laurence H BeckBoston University School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.
Stephen P BerasiPfizer Inc., Cambridge, Massachusetts, USA.
J Brian CopleyPfizer Inc., Cambridge, Massachusetts, USA.
Donal GormanPfizer Inc., Cambridge, United Kingdom.
Daniel I LevyPfizer Inc., Cambridge, Massachusetts, USA.
Chay Ngee LimPfizer Inc., Cambridge, Massachusetts, USA.
Joel M HendersonBoston University School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.
David J SalantBoston University School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.
Weining LuBoston University School of Medicine, Boston Medical Center, Boston, Massachusetts, USA.
Boston University · USPfizer (United States) · USPfizer (United Kingdom) · GB

Funding

Molecular Pathogenesis of Vesicoureteral RefluxR01DK078226 · NIDDK · BOSTON MEDICAL CENTER · PI LU, WEINING · 2008 to 2018
$2.5M
New Therapeutic Leads for Proteinuric Kidney DiseasesR01DK133940 · NIDDK · BOSTON MEDICAL CENTER · PI LU, WEINING · 2022 to 2024
$790k
NIDDK NIH HHS R01 DK078226NIDDK NIH HHS R01 DK133940
6 · The paper itself

Abstract

introductionFocal segmental glomerulosclerosis (FSGS) is characterized by proteinuria and a histologic pattern of glomerular lesions of diverse etiology that share features including glomerular scarring and podocyte foot process effacement. Roundabout guidance receptor 2 (ROBO2)/slit guidance ligand 2 (SLIT2) signaling destabilizes the slit diaphragm and reduces podocyte adhesion to the glomerular basement membrane (GBM). Preclinical studies suggest that inhibition of glomerular ROBO2/SLIT2 signaling can stabilize podocyte adhesion and reduce proteinuria. This clinical trial evaluates the preliminary efficacy and safety of ROBO2/SLIT2 inhibition with the ROBO2 fusion protein PF-06730512 in patients with FSGS.

methodsThe Study to Evaluate PF-06730512 in Adults With FSGS (PODO; ClinicalTrials.gov identifier NCT03448692), an open-label, phase 2a, multicenter trial in adults with FSGS, will enroll patients into 2 cohorts (n = 22 per cohort) to receive either high- or low-dose PF-06730512 (intravenous) every 2 weeks for 12 weeks. Key inclusion criteria include a confirmed biopsy diagnosis of FSGS, an estimated glomerular filtration rate (eGFR) ≥45 ml/min/1.73 m

resultsThis ongoing trial will report the efficacy, safety, pharmacokinetics, and biomarker results of PF-06730512 for patients with FSGS.

conclusionFindings from this proof-of-concept study may support further development and evaluation of PF-06730512 to treat FSGS and warrant assessment in phase 3 clinical trials.

Indexed as

efficacyfocal segmental glomerulosclerosispharmacokineticsROBO2safetytrial in progress

Identifiers

PMID34169203
PMCPMC8207305
OpenAlexW3139657475

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.