Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

A study of Molidustat for correction of renal anemia in dialysis subjects (MIYABI HD-C)

Bayer Identifier:

19351

ClinicalTrials.gov Identifier:

NCT03351166

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)

Inclusion Criteria
- Subject with end-stage kidney disease (ESKD) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly 
- Body weight > 40 and ≤ 160 kg at screening
- Male or female subject ≥ 20 years of age at screening
- At least one kidney
- Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol
- Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and < 10.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment
- Ferritin ≥ 50 ng/mL 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 and poorly controlled arterial hypertension (defined as systolic BP≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization
- Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)

Trial Summary

Enrollment Goal
25
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Musredo (Molidustat, BAY85-3934)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Itami Kidney Clinic

Noboribetsu, Japan, 059-0026

Status
Completed
 
Locations

Ishikari Hospital

Ishikari, Japan, 061-3213

Status
Completed
 
Locations

Japanese Red Cross Ishinomaki Hospital

Ishinomaki, Japan, 986-8522

Status
Completed
 
Locations

Tokiwa Clinic

Totte, Japan, 302-0011

Status
Completed
 
Locations

Kikuchi Medical Clinic

Tsukuba, Japan, 305-0861

Status
Completed
 
Locations

Asahikawa-Kosei General Hospital

Asahikawa, Japan, 078-8211

Status
Completed
 
Locations

Souen Central Hospital

Sapporo, Japan, 060-0008

Status
Completed
 
Locations

Yamagata Tokushukai Hospital

Yamagata, Japan, 990-0834

Status
Completed
 
Locations

Tsuchiura Beryl Clinic

Tsuchiura, Japan, 300-0062

Status
Completed
 
Locations

Ohmiya Chuo General Hospital

Saitama, Japan, 331-8711

Status
Completed
 
Locations

Matsunami General Hospital

Hashima-gun, Japan, 501-6062

Status
Completed
 
Locations

Toyonaka Keijinkai Clinic

Toyonaka, Japan, 560-0004

Status
Completed
 
Locations

Takasago Seibu Hospital

Takasago, Japan, 676-0812

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

Houshikai Kano hospital

Kasuya-gun, Japan, 811-0120

Status
Completed
 
Locations

Fukuoka Renal Clinic

Fukuoka, Japan, 810-0004

Status
Completed
 
Locations

Medical corporation association Shunshin-kai Inage hospital

Chiba, Japan, 263-0043

Status
Completed
 
Locations

Iida Hospital

Iida, Japan, 395-8505

Status
Completed
 
Locations

Kodaira Kitaguchi Clinic

Kodaira, Japan, 187-0001

Status
Completed
 

Trial Design