Study Details

A study of Intermittent Oral Dosing of ASP1517 in ESA-untreated chronic kidney disease patients with Anemia

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02964936

Astellas Study ID

The unique identification code given by the study sponsor.

1517-CL-0314

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Kidney Disease

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

20 years - N/A

Sex

Female & Male

Product

roxadustat

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jan 2017 - Aug 2018

Masking

None (Open Label)

Enrollment number

100

A Phase 3, Multicenter, Randomized, 2-Arm, Open-label Study of Intermittent Oral Dosing of ASP1517 for the Treatment of Anemia in Erythropoiesis Stimulating Agent-untreated Chronic Kidney Disease Patients Not on Dialysis

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site JP00014

Kanagawa, Japan

Site JP00036

Hiroshima, Japan

Site JP00028

Aichi, Japan

Site JP00026

Osaka, Japan

Site JP00001

Chiba, Japan

Site JP00032

Oita, Japan

Site JP00023

Tokyo, Japan

Site JP00006

Kanagawa, Japan

Site JP00034

Hiroshima, Japan

Site JP00024

Niigata, Japan

Site JP00025

Ibaraki, Japan

Site JP00033

Ishikawa, Japan

Site JP00035

Ehime, Japan

Site JP00010

Miyagi, Japan

Site JP00030

Hiroshima, Japan

Site JP00016

Nagano, Japan

Site JP00012

Fukui, Japan

Site JP00009

Osaka, Japan

Site JP00002

Saitama, Japan

Site JP00021

Ibaraki, Japan

Site JP00022

Tokyo, Japan

Site JP00004

Tokyo, Japan

Site JP00038

Kanagawa, Japan

Site JP00037

Ibaraki, Japan

Site JP00007

Aichi, Japan

Site JP00027

Saitama, Japan

Site JP00031

Fukuoka, Japan

Site JP00017

Ibaraki, Japan

Site JP00018

Aichi, Japan

Site JP00019

Saitama, Japan

Site JP00003

Osaka, Japan

Site JP00020

Hyogo, Japan

Site JP00015

Ibaraki, Japan

Site JP00011

Fukuoka, Japan

Site JP00005

Hokkaido, Japan

Site JP00029

Iwate, Japan

Site JP00008

Toyama, Japan

Site JP00013

Tokyo, Japan