Study Details

A study of intermittent oral dosing of ASP1517 in Erythropoieses Stimulating Agent (ESA)-naive hemodialysis 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.
NCT02780141

Astellas Study ID

The unique identification code given by the study sponsor.

1517-CL-0308

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 with Anemia

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

N/A

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

Jun 2016 - Dec 2017

Masking

None (Open Label)

Enrollment number

75

A Phase 3, multi-center, randomized, 2-arm, open-label study of intermittent oral dosing of ASP1517 in erythropoiesis stimulating agent-naive hemodialysis chronic kidney disease patients with anemia

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

Nagano, Japan

Site JP00026

Nagano, Japan

Site JP00030

Ibaraki, Japan

Site JP00010

Ehime, Japan

Site JP00016

Gunma, Japan

Site JP00037

Kumamoto, Japan

Site JP00047

Nagano, Japan

Site JP00043

Tokushima, Japan

Site JP00006

Saitama, Japan

Site JP00024

Okinawa, Japan

Site JP00036

Osaka, Japan

Site JP00022

Ishikawa, Japan

Site JP00027

Ibaraki, Japan

Site JP00029

Niigata, Japan

Site JP00038

Hokkaido, Japan

Site JP00034

Hyogo, Japan

Site JP00031

Kumamoto, Japan

Site JP00023

Hokkaido, Japan

Site JP00046

Hiroshima, Japan

Site JP00019

Toyama, Japan

Site JP00028

Hokkaido, Japan

Site JP00012

Gunma, Japan

Site JP00002

Niigata, Japan

Site JP00044

Aichi, Japan

Site JP00004

Yamaguchi, Japan

Site JP00017

Gifu, Japan

Site JP00018

Ibaraki, Japan

Site JP00032

Shizuoka, Japan

Site JP00013

Fukuoka, Japan

Site JP00040

Hokkaido, Japan

Site JP00025

Gunma, Japan

Site JP00008

Ibaraki, Japan

Site JP00020

Chiba, Japan

Site JP00039

Okayama, Japan

Site JP00035

Fukushima, Japan

Site JP00007

Tottori, Japan

Site JP00005

Aichi, Japan

Site JP00011

Fukushima, Japan

Site JP00003

Aichi, Japan

Site JP00033

Gifu, Japan

Site JP00048

Tokyo, Japan

Site JP00042

Aichi, Japan

Site JP00015

Hokkaido, Japan

Site JP00041

Kagoshima, Japan

Site JP00021

Ehime, Japan

Site JP00045

Hokkaido, Japan

Site JP00009

Nagano, Japan