Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study.
Aged
Anemia
/ blood
Double-Blind Method
Endpoint Determination
Female
Glycine
/ adverse effects
Hematinics
/ adverse effects
Hemoglobins
/ metabolism
Humans
Hypoxia-Inducible Factor-Proline Dioxygenases
/ antagonists & inhibitors
Isoquinolines
/ adverse effects
Male
Middle Aged
Prolyl-Hydroxylase Inhibitors
/ adverse effects
Renal Insufficiency, Chronic
/ blood
Safety
anemia
chronic kidney disease
clinical nephrology
clinical trial
randomized controlled trials
Journal
Journal of the American Society of Nephrology : JASN
ISSN: 1533-3450
Titre abrégé: J Am Soc Nephrol
Pays: United States
ID NLM: 9013836
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
09
08
2020
accepted:
01
12
2020
pubmed:
12
2
2021
medline:
22
9
2021
entrez:
11
2
2021
Statut:
ppublish
Résumé
Current anemia therapies for patients with non-dialysis-dependent CKD may require injection and medical visits. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates erythropoiesis and improves iron homeostasis. In this double-blind phase 3 study, we randomized patients with non-dialysis-dependent CKD stages 3-5 and hemoglobin <10.0 g/dl (1:1) to thrice-weekly 70-mg oral roxadustat or placebo. Doses were titrated throughout the study based on hemoglobin levels. The primary efficacy end point was mean change from baseline in hemoglobin averaged over weeks 28-52 versus placebo, irrespective of rescue therapy use. We assessed patients for adverse events. The study included 2781 patients, 1393 who received roxadustat and 1388 who received placebo. Mean baseline hemoglobin was 9.1 g/dl for both groups. The mean change in hemoglobin from baseline was 1.75 g/dl (95% confidence interval [95% CI], 1.68 to 1.81) with roxadustat versus 0.40 g/dl (95% CI, 0.33 to 0.47) with placebo, ( Roxadustat effectively increased hemoglobin in patients with non-dialysis-dependent CKD and reduced the need for red blood cell transfusion, with an adverse event profile comparable to that of placebo. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With CKD, Not on Dialysis, NCT02174627.
Sections du résumé
BACKGROUND
Current anemia therapies for patients with non-dialysis-dependent CKD may require injection and medical visits. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates erythropoiesis and improves iron homeostasis.
METHODS
In this double-blind phase 3 study, we randomized patients with non-dialysis-dependent CKD stages 3-5 and hemoglobin <10.0 g/dl (1:1) to thrice-weekly 70-mg oral roxadustat or placebo. Doses were titrated throughout the study based on hemoglobin levels. The primary efficacy end point was mean change from baseline in hemoglobin averaged over weeks 28-52 versus placebo, irrespective of rescue therapy use. We assessed patients for adverse events.
RESULTS
The study included 2781 patients, 1393 who received roxadustat and 1388 who received placebo. Mean baseline hemoglobin was 9.1 g/dl for both groups. The mean change in hemoglobin from baseline was 1.75 g/dl (95% confidence interval [95% CI], 1.68 to 1.81) with roxadustat versus 0.40 g/dl (95% CI, 0.33 to 0.47) with placebo, (
CONCLUSIONS
Roxadustat effectively increased hemoglobin in patients with non-dialysis-dependent CKD and reduced the need for red blood cell transfusion, with an adverse event profile comparable to that of placebo.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With CKD, Not on Dialysis, NCT02174627.
Identifiants
pubmed: 33568383
pii: 00001751-202103000-00023
doi: 10.1681/ASN.2020081150
pmc: PMC7920165
doi:
Substances chimiques
Hematinics
0
Hemoglobins
0
Isoquinolines
0
Prolyl-Hydroxylase Inhibitors
0
Hypoxia-Inducible Factor-Proline Dioxygenases
EC 1.14.11.29
Glycine
TE7660XO1C
roxadustat
X3O30D9YMX
Banques de données
ClinicalTrials.gov
['NCT02174627']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
737-755Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2021 by the American Society of Nephrology.
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