Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

Maintenance treatment of renal anemia in dialysis subjects (MIYABI HD-M)

Bayer Identifier:

19352

ClinicalTrials.gov Identifier:

NCT03543657

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).

Inclusion Criteria
- Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization
- Body weight (after dialysis) > 40 and ≤ 160 kg at screening
- Male or female subject ≥ 20 years of age at screening
- At least one kidney
- Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization
- Mean screening Hb level ≥ 9.5 and < 12.0 g/dL (mean of all central  laboratory Hb levels before dialysis [at least 2 measurements must be taken ≥ 2 days apart] during the screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is < 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization
- Ferritin ≥ 100 ng/mL or transferrin saturation ≥ 20% at screening
- Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) at screening
Exclusion Criteria
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization
- Sustained, poorly controlled arterial hypertension (defined as systolic BP (blood pressure) ≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization
- Proliferative choroidal or retinal disease, such as neovascular agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening

Trial Summary

Enrollment Goal
229
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Asahikawa-Kosei General Hospital

Asahikawa, Japan, 078-8211

Status
Completed
 
Locations

Itami Kidney Clinic

Noboribetsu, Japan, 059-0026

Status
Completed
 
Locations

Ishikari Hospital

Ishikari, Japan, 061-3213

Status
Completed
 
Locations

Souen Central Hospital

Sapporo, Japan, 060-0008

Status
Completed
 
Locations

Seisuikai Yoshioka Mahoroba Clinic

Kurokawa-gun, Japan, 981-3632

Status
Completed
 
Locations

Eijinkai Hospital

Osaki, Japan, 989-6117

Status
Completed
 
Locations

Yamagata Tokushukai Hospital

Yamagata, Japan, 990-0834

Status
Completed
 
Locations

Tsuchiura Beryl Clinic

Tsuchiura, Japan, 300-0062

Status
Completed
 
Locations

Tokiwa Clinic

Totte, Japan, 302-0011

Status
Completed
 
Locations

Kikuchi Medical Clinic

Tsukuba, Japan, 305-0861

Status
Completed
 
Locations

Mito Kyodo General Hospital

Mito, Japan, 310-0015

Status
Completed
 
Locations

Japanese Red Cross Koga Hospital

Koga, Japan, 306-0014

Status
Completed
 
Locations

Ibaraki Prefectural Central Hospital

Kasama, Japan, 309-1793

Status
Completed
 
Locations

Todachuo General Hospital

Toda, Japan, 335-0023

Status
Completed
 
Locations

Saiyu Clinic

Koshigaya, Japan, 343-0823

Status
Completed
 
Locations

Higashimatsuyamakohjin Clinic

Higashimatsuyama, Japan, 355-0016

Status
Completed
 
Locations

Kisarazu Clinic

Kisarazu, Japan, 292-0805

Status
Completed
 
Locations

Medical corporation association Shunshin-kai Inage hospital

Chiba, Japan, 263-0043

Status
Completed
 
Locations

Shinkashiwa Clinic

Kashiwa, Japan, 277-0084

Status
Completed
 
Locations

Kodaira Kitaguchi Clinic

Kodaira, Japan, 187-0001

Status
Completed
 
Locations

Chigasaki Central Clinic

Chigasaki, Japan, 253-0052

Status
Completed
 
Locations

Yokohama Jin Clinic

Yokohama, Japan, 224-0032

Status
Completed
 
Locations

Eda Clinic

Yokohama, Japan, 225-0015

Status
Completed
 
Locations

Kaminagaya Saitou Clinic

Yokohama, Japan, 233-0013

Status
Completed
 
Locations

Honatsugi Medical Clinic

Atsugi, Japan, 243-0013

Status
Completed
 
Locations

Sabae kidney Clinic

Sabae, Japan, 916-0044

Status
Completed
 
Locations

Maruko Central Hospital

Ueda, Japan, 386-0405

Status
Completed
 
Locations

Iida Hospital

Iida, Japan, 395-8505

Status
Completed
 
Locations

Matsumoto City Hospital

Matsumoto, Japan, 390-1401

Status
Completed
 
Locations

Kanno Dialysis & Vascular Access Clinic

Matsumoto, Japan, 390-0821

Status
Completed
 
Locations

Medical Corporation Suzukihinyoukika

Nagano, Japan, 380-0904

Status
Completed
 
Locations

Hakuyoukai Medical corporation Hakuyoukai Hospital

Nagoya, Japan, 465-0025

Status
Completed
 
Locations

Toyonaka Keijinkai Clinic

Toyonaka, Japan, 560-0004

Status
Completed
 
Locations

Chibune Clinic

Osaka, Japan, 555-0001

Status
Completed
 
Locations

Akagaki Clinic

Osaka, Japan, 543-0052

Status
Completed
 
Locations

Nishi Shinryosho

Osaka, Japan, 552-0007

Status
Completed
 
Locations

Arisawa General Hospital

Hirakata, Japan, 573-1195

Status
Completed
 
Locations

Saint Hill Hospital

Ube, Japan, 755-0155

Status
Completed
 
Locations

Kaisei Hospital

Sakaide, Japan, 762-0007

Status
Completed
 
Locations

Kuwajima Clinic

Niihama, Japan, 792-0812

Status
Completed
 
Locations

Houshikai Kano hospital

Kasuya-gun, Japan, 811-0120

Status
Completed
 
Locations

Saiseikai Yahata General Hospital

Kitakyushu, Japan, 805-0050

Status
Completed
 
Locations

Ikeda Vascular Access Nephrology Dialysis

Fukuoka, Japan, 810-0012

Status
Completed
 
Locations

Oohashi internal medicine circulatory Clinic

Fukuoka, Japan, 815-0038

Status
Completed
 
Locations

Nagasaki Kidney Hospital

Nagasaki, Japan, 850-0032

Status
Completed
 
Locations

Ueki Imafuji Clinic

Kumamoto, Japan, 861-0135

Status
Completed
 
Locations

Public Central Hospital of Matto Ishikawa

Hakusan, Japan, 924-8588

Status
Completed
 
Locations

Koizumi Cardiology Medical Clinic

Chitose, Japan, 066-0062

Status
Completed
 
Locations

Sanshikai Toho Hospital

Midori, Japan, 379-2311

Status
Completed
 
Locations

Hanyu General Hospital

Hanyu, Japan, 348-0045

Status
Completed
 
Locations

Iwatsuki-minami Hospital

Saitama, Japan, 339-0033

Status
Completed
 
Locations

Hachioji Azumacho Clinic

Hachioji, Japan, 192-0082

Status
Completed
 
Locations

Toshiba Rinkan Hospital

Sagamihara, Japan, 252-0385

Status
Completed
 

Trial Design