Maintenance Treatment of Renal Anemia in Dialysis Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

229

Participants

Timeline

Start Date

June 23, 2018

Primary Completion Date

August 7, 2019

Study Completion Date

December 24, 2019

Conditions
AnemiaRenal Insufficiency, Chronic
Interventions
DRUG

Molidustat (BAY85-3934)

Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).

DRUG

Darbepoetin alfa

Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.

DRUG

Placebo of Molidustat (BAY85-3934)

Matching placebo of Molidustat.

DRUG

Placebo of Darbepoetin alfa

Matching placebo of Darbepoetin alfa.

Trial Locations (53)

465-0025

Hakuyoukai Medical corporation Hakuyoukai Hospital, Nagoya

277-0084

Shinkashiwa Clinic, Kashiwa

292-0805

Kisarazu Clinic, Kisarazu

792-0812

Kuwajima Clinic, Niihama

916-0044

Sabae kidney Clinic, Sabae

811-0120

Houshikai Kano hospital, Kasuya-gun

805-0050

Saiseikai Yahata General Hospital, Kitakyushu

379-2311

Sanshikai Toho Hospital, Midori

078-8211

Asahikawa-Kosei General Hospital, Asahikawa

066-0062

Koizumi Cardiology Medical Clinic, Chitose

061-3213

Ishikari Hospital, Ishikari

059-0026

Itami Kidney Clinic, Noboribetsu

060-0008

Souen Central Hospital, Sapporo

309-1793

Ibaraki Prefectural Central Hospital, Kasama

306-0014

Japanese Red Cross Koga Hospital, Koga

310-0015

Mito Kyodo General Hospital, Mito

302-0011

Tokiwa Clinic, Totte

300-0062

Tsuchiura Beryl Clinic, Tsuchiura

305-0861

Kikuchi Medical Clinic, Tsukuba

924-8588

Public Central Hospital of Matto Ishikawa, Hakusan

762-0007

Kaisei Hospital, Sakaidechō

243-0013

Honatsugi Medical Clinic, Atsugi

253-0052

Chigasaki Central Clinic, Chigasaki

252-0385

Toshiba Rinkan Hospital, Sagamihara

224-0032

Yokohama Jin Clinic, Yokohama

225-0015

Eda Clinic, Yokohama

233-0013

Kaminagaya Saitou Clinic, Yokohama

981-3632

Seisuikai Yoshioka Mahoroba Clinic, Kurokawa-gun

989-6117

Eijinkai Hospital, Ōsaki

395-8505

Iida Hospital, Iida

390-0821

Kanno Dialysis & Vascular Access Clinic, Matsumoto

390-1401

Matsumoto City Hospital, Matsumoto

386-0405

Maruko Central Hospital, Ueda

573-1195

Arisawa General Hospital, Hirakata

560-0004

Toyonaka Keijinkai Clinic, Toyonaka

348-0045

Hanyu General Hospital, Hanyū

355-0016

Higashimatsuyamakohjin Clinic, Higashi-Matsuyama

343-0823

Saiyu Clinic, Koshigaya

335-0023

Todachuo General Hospital, Toda

192-0082

Hachioji Azumacho Clinic, Hachiōji

187-0001

Kodaira Kitaguchi Clinic, Kodaira

755-0155

Saint Hill Hospital, Ube

263-0043

Medical corporation association Shunshin-kai Inage hospital, Chiba

810-0012

Ikeda Vascular Access Nephrology Dialysis, Fukuoka

815-0038

Oohashi internal medicine circulatory Clinic, Fukuoka

861-0135

Ueki Imafuji Clinic, Kumamoto

380-0904

Medical Corporation Suzukihinyoukika, Nagano

850-0032

Nagasaki Kidney Hospital, Nagasaki

543-0052

Akagaki Clinic, Osaka

552-0007

Nishi Shinryosho, Osaka

555-0001

Chibune Clinic, Osaka

339-0033

Iwatsuki-minami Hospital, Saitama

990-0834

Yamagata Tokushukai Hospital, Yamagata

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY