Trial Condition(s):

Anemia, Renal Insufficiency, Chronic

A study of Molidustat for maintenance treatment of renal anemia in non-dialysis subjects (MIYABI ND-M)

Bayer Identifier:

19350

ClinicalTrials.gov Identifier:

NCT03350347

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)

Inclusion Criteria
- Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic kidney disease [CKD] stages 3 to 5)
- Have used the same ESA for 8 weeks prior to screening
- Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization
- Body weight > 40 and ≤ 160 kg at screening
- Male or female subject ≥ 20 years of age at screening
- Not on dialysis and not expected to start dialysis during the study period
- Mean screening Hb level ≥ 10.0 and < 13.0 g/dL (mean of all central laboratory Hb levels [at least 2 measurements must be taken ≥ 2 days apart] during the 8-week 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%
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 (blood pressure)≥ 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
164
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

Teine Keijinkai Clinic

Sapporo, Japan, 006-8555

Status
Completed
Locations

Japanese Red Cross Ishinomaki Hospital

Ishinomaki, Japan, 986-8522

Status
Completed
Locations

Mito Kyodo General Hospital

Mito, Japan, 310-0015

Status
Completed
Locations

Kitasato University Medical Center

Kitamoto, Japan, 364-8501

Status
Completed
Locations

Seikeikai New Tokyo Heart Clinic

Matsudo, Japan, 271-0077

Status
Completed
Locations

Nihon University Itabashi Hospital

Itabashi-ku, Japan, 173-8610

Status
Completed
Locations

Showa University Koto Toyosu Hospital

Koto-ku, Japan, 135-8577

Status
Completed
Locations

Fujisawa City Hospital

Fujisawa, Japan, 251-8550

Status
Completed
Locations

Showa University Fujigaoka Hospital

Yokohama, Japan, 227-8501

Status
Completed
Locations

Yokosuka Kyosai Hospital

Yokosuka, Japan, 238-8558

Status
Completed
Locations

Koukan Clinic

Kawasaki, Japan, 210-0852

Status
Completed
Locations

Niigata Prefectural Shibata Hospital

Shibata, Japan, 957-8588

Status
Completed
Locations

Public Central Hospital of Matto Ishikawa

Hakusan, Japan, 924-8588

Status
Completed
Locations

Fukui Prefectural Hospital

Fukui, Japan, 910-8526

Status
Completed
Locations

University of Yamanashi Hospital

Chuo, Japan, 409-3898

Status
Completed
Locations

Asama Nanroku Komoro Medical Center

Komoro, Japan, 384-8588

Status
Completed
Locations

Asahi University Hospital

Gifu, Japan, 500-8523

Status
Completed
Locations

Suruga Clinic

Shizuoka, Japan, 424-0855

Status
Completed
Locations

Iwata City Hospital

Iwata, Japan, 438-8550

Status
Completed
Locations

Shizuoka Saiseikai General Hospital

Shizuoka, Japan, 422-8527

Status
Completed
Locations

Kainan Hospital

Yatomi, Japan, 498-8502

Status
Completed
Locations

JCHO Yokkaichi Hazu Medical Center

Yokkaichi, Japan, 510-0016

Status
Completed
Locations

Chibune Clinic

Osaka, Japan, 555-0001

Status
Completed
Locations

Yodogawa Christian Hospital

Osaka, Japan, 533-0024

Status
Completed
Locations

Kitano Hospital

Osaka, Japan, 530-8480

Status
Completed
Locations

Osaka Pref. Saiseikai Tondabayashi Hospital

Tondabayashi, Japan, 584-0082

Status
Completed
Locations

Social Corporation Keigakukai Minamiosaka Hospital

Osaka, Japan, 559-0012

Status
Completed
Locations

Nippon Life Hospital

Osaka, Japan, 550-0006

Status
Completed
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
Locations

National Hospital Organization Kobe Medical Center

Kobe, Japan, 654-0155

Status
Completed
Locations

Nara Prefecture General Medical Center

Nara, Japan, 630-8581

Status
Completed
Locations

Nippon Kokan Fukuyama Hospital

Fukuyama, Japan, 721-0927

Status
Completed
Locations

Mazda Hospital of Mazda Motor Corporation

Aki-gun, Japan, 735-8585

Status
Completed
Locations

Higashihiroshima Medical Center

Higashihiroshima, Japan, 739-0041

Status
Completed
Locations

KenAiKai medical corporation Akiyama clinic

Takamatsu, Japan, 761-1701

Status
Completed
Locations

Ehime Prefectural Central Hospital

Matsuyama, Japan, 790-0024

Status
Completed
Locations

Saiseikai Matsuyama Hospital

Matsuyama, Japan, 791-8026

Status
Completed
Locations

Iizuka Hospital

Iizuka, Japan, 820-8505

Status
Completed
Locations

Fukuoka University Hospital

Fukuoka, Japan, 814-0180

Status
Completed
Locations

Kokura Memorial Hospital

Kitakyushu, Japan, 802-8555

Status
Completed
Locations

Steel Memorial Yawata Hospital

Kitakyushu, Japan, 805-8508

Status
Completed
Locations

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Status
Completed
Locations

Kurume University Hospital

Kurume, Japan, 830-0011

Status
Completed
Locations

St.Mary's Hospital

Kurume, Japan, 830-8543

Status
Completed
Locations

National Fukuoka-Higashi Medical Center

Koga, Japan, 811-3195

Status
Completed
Locations

Japanese Red Cross Oita Hospital

Oita, Japan, 870-0033

Status
Completed
Locations

Ikeda Hospital

Kanoya, Japan, 893-0024

Status
Completed
Locations

Toshima Hospital

Itabashi-ku, Japan, 173-0015

Status
Completed
Locations

National Hospital Organization Tokyo Medical Center

Meguro-ku, Japan, 152-8902

Status
Completed
Locations

National Hospital Organization Kochi National Hospital

Kochi, Japan, 780-8077

Status
Completed
Locations

Matsunami Health Promotion Clinic

Hashima-gun, Japan, 501-6061

Status
Completed
Locations

National Hospital Organization Osaka National Hospital

Osaka, Japan, 540-0006

Status
Completed
Locations

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan, 810-8563

Status
Completed
Locations

Arao Municipal Hospital

Arao, Japan, 864-0041

Status
Completed
Locations

Wakayama Medical University Hospital

Wakayama, Japan, 641-8510

Status
Completed
Locations

Osaka Red Cross Hospital

Osaka, Japan, 543-8555

Status
Completed
Locations

Kobe City Medical Center General Hospital

Kobe, Japan, 650-0047

Status
Completed
Locations

R.I.A.C Naha City Hospital

Naha, Japan, 902-8511

Status
Completed
Locations

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Japan, 880-8510

Status
Completed

Trial Design