Evidence map›Paper›PMID 35497806›Full record

ArticleKidney international reports2022

Two Phase 3 Studies on Ophthalmologic Effects of Roxadustat Versus Darbepoetin.

Yasir J Sepah, Quan Dong Nguyen, Yusuke Yamaguchi, Tetsuro Otsuka, Yoshikatsu Majikawa, Michael Reusch, Tadao Akizawa

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Kidney international reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 22% 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.

NCT02952092 phase3completednot on this map

A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia

TypeinterventionalSponsorAstellas Pharma IncRan2016 to 2018Enrolled303ConditionsHemodialysis Chronic Kidney Disease Patients With AnemiaArmsroxadustat, Darbepoetin alfa
NCT02988973 phase3completednot on this map

A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney Disease Patients With Anemia

TypeinterventionalSponsorAstellas Pharma IncRan2017 to 2020Enrolled334ConditionsChronic Kidney DiseaseArmsroxadustat, DA
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Systemic Cytokines in Retinopathy of Prematurity.Journal of personalized medicine · 2023
    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

7 authors at 4 institutions in 3 countries.

Yasir J SepahSpencer Center for Vision Research, Byers Eye Institute, Stanford School of Medicine, Stanford, California, USA.
Quan Dong NguyenSpencer Center for Vision Research, Byers Eye Institute, Stanford School of Medicine, Stanford, California, USA.
Yusuke YamaguchiAstellas Pharma, Inc., Tokyo, Japan.
Tetsuro OtsukaAstellas Pharma, Inc., Tokyo, Japan.
Yoshikatsu MajikawaAstellas Pharma, Inc., Tokyo, Japan.
Michael ReuschAstellas Pharma Europe B.V., Leiden, The Netherlands.
Tadao AkizawaShowa University School of Medicine, Tokyo, Japan.
Astellas Pharma (Japan) · JPAstellas Pharma (Netherlands) · NLOcular Surface Center · USShowa University · JP

Funding

Stanford Vision Research CoreP30EY026877 · NEI · STANFORD UNIVERSITY · PI Jeffrey L Goldberg · 2017 to 2026
$8.0M
NEI NIH HHS P30 EY026877
6 · The paper itself

Abstract

Introduction: Roxadustat is an orally administered hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor that represents a novel therapeutic option for patients with anemia of chronic kidney disease (CKD). Methods: Conducted in Japan, CL-0307 (NCT02952092) and CL-310 (NCT02988973) were phase 3, darbepoetin alfa (DA)-controlled studies conducted in dialysis-dependent (DD) and non-DD (NDD) patients with CKD, respectively, where patients were randomized to receive roxadustat or DA. Ophthalmic imaging and assessments of visual acuity were performed up to week 24 or at study discontinuation. Ophthalmic imaging was centrally evaluated by independent readers masked to the study treatment. Results: In CL-0307, 302 patients (roxadustat, Conclusion: In these studies, roxadustat, compared with DA, was not associated with an increased risk of adverse ophthalmologic events in these cohorts.

Indexed as

active comparatoranemiachronic kidney diseaseophthalmologic safetyretinal hemorrhageroxadustat

Identifiers

PMID35497806
PMCPMC9039484
OpenAlexW4206307468

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.