Trial Condition(s):
Anemia, Renal Insufficiency, Chronic
A study of Molidustat for correction of renal anemia in non-dialysis subjects (MIYABI ND-C)
Bayer Identifier:
19349
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects with renal anemia who are not 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) - 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 - Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization - Mean of the last 2 central laboratory Hb levels during the screening period must be ≥ 8.0 and < 11.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) and the last measurements must be taken within 14 days prior to randomization - 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Teine Keijinkai Clinic Sapporo, Japan, 006-8555 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Japanese Red Cross Ishinomaki Hospital Ishinomaki, Japan, 986-8522 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fukushima Medical University Hospital Fukushima, Japan, 960-1295 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mito Kyodo General Hospital Mito, Japan, 310-0015 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National hospital Organization Mito Medical Center Higashiibaraki, Japan, 311-3193 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kitasato University Medical Center Kitamoto, Japan, 364-8501 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seikeikai New Tokyo Heart Clinic Matsudo, Japan, 271-0077 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nihon University Itabashi Hospital Itabashi-ku, Japan, 173-8610 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Showa University Koto Toyosu Hospital Koto-ku, Japan, 135-8577 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fujisawa City Hospital Fujisawa, Japan, 251-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Showa University Fujigaoka Hospital Yokohama, Japan, 227-8501 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yokosuka Kyosai Hospital Yokosuka, Japan, 238-8558 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Koukan Clinic Kawasaki, Japan, 210-0852 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Niigata Prefectural Shibata Hospital Shibata, Japan, 957-8588 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fukui Prefectural Hospital Fukui, Japan, 910-8526 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Yamanashi Hospital Chuo, Japan, 409-3898 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asama Nanroku Komoro Medical Center Komoro, Japan, 384-8588 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asahi University Hospital Gifu, Japan, 500-8523 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Suruga Clinic Shizuoka, Japan, 424-0855 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Iwata City Hospital Iwata, Japan, 438-8550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shizuoka Saiseikai General Hospital Shizuoka, Japan, 422-8527 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kainan Hospital Yatomi, Japan, 498-8502 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations JCHO Yokkaichi Hazu Medical Center Yokkaichi, Japan, 510-0016 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uji-Tokushukai Medical Center Uji, Japan, 611-0041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chibune Clinic Osaka, Japan, 555-0001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kitano Hospital Osaka, Japan, 530-8480 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka Pref. Saiseikai Tondabayashi Hospital Tondabayashi, Japan, 584-0082 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Social Corporation Keigakukai Minamiosaka Hospital Osaka, Japan, 559-0012 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nippon Life Hospital Osaka, Japan, 550-0006 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Kobe Medical Center Kobe, Japan, 654-0155 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nippon Kokan Fukuyama Hospital Fukuyama, Japan, 721-0927 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mazda Hospital of Mazda Motor Corporation Aki-gun, Japan, 735-8585 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations KenAiKai medical corporation Akiyama clinic Takamatsu, Japan, 761-1701 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ehime Prefectural Central Hospital Matsuyama, Japan, 790-0024 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Saiseikai Matsuyama Hospital Matsuyama, Japan, 791-8026 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Iizuka Hospital Iizuka, Japan, 820-8505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fukuoka University Hospital Fukuoka, Japan, 814-0180 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Steel Memorial Yawata Hospital Kitakyushu, Japan, 805-8508 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kurume University Hospital Kurume, Japan, 830-0011 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St.Mary's Hospital Kurume, Japan, 830-8543 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Fukuoka-Higashi Medical Center Koga, Japan, 811-3195 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Japanese Red Cross Oita Hospital Oita, Japan, 870-0033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ikeda Hospital Kanoya, Japan, 893-0024 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Okinawa prefectural Chubu Hospital Uruma, Japan, 904-2293 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Toshima Hospital Itabashi-ku, Japan, 173-0015 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Tokyo Medical Center Meguro-ku, Japan, 152-8902 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Kochi National Hospital Kochi, Japan, 780-8077 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Matsunami Health Promotion Clinic Hashima-gun, Japan, 501-6061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Osaka National Hospital Osaka, Japan, 540-0006 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka Saiseikai Senri Hospital Suita, Japan, 565-0862 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Hospital Organization Kyushu Medical Center Fukuoka, Japan, 810-8563 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kumamoto Rosai Hospital Yatsushiro, Japan, 866-8533 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Arao Municipal Hospital Arao, Japan, 864-0041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wakayama Medical University Hospital Wakayama, Japan, 641-8510 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka Red Cross Hospital Osaka, Japan, 543-8555 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kobe City Medical Center General Hospital Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nara Prefecture General Medical Center Nara, Japan, 630-8581 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gifu Prefectural Tajimi Hospital Tajimi, Japan, 507-8522 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A randomized, open-label, active-controlled, parallel-group, multicenter study to investigate the efficacy and safety of oral molidustat in comparison to darbepoetin alfa in non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Mean Hb (Hemoglobin) levelTimeframe: From week 30 to 36
- Change in hemoglobin level from baseline to the average during the evaluation periodTimeframe: Baseline and week 30 to 36
Secondary Outcome
- Responder rate: proportion of responders among the subjectsResponder is defined as meeting all of the following criteria: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatmentTimeframe: From week 30 to 36
- Rate of rise in Hb (Hemoglobin) level (g/dL/week)Timeframe: Up to 8 weeks
- Rate of rise in Hb (Hemoglobin) level (g/dL/week)Timeframe: Up to 4 weeks
- Proportion of subjects who meet each component of the responseResponse: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatmentTimeframe: From week 30 to 36
- Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least onceTimeframe: Up to 52 weeks
- Change in Hb levelTimeframe: Baseline and up to 52 weeks
- Hb levelTimeframe: Baseline and up to 52 weeks
- Proportion of subjects whose mean hemoglobin level is in the target rangeTimeframe: From week 30 to 36
- Proportion of subjects whose mean hemoglobin level is above the target rangeTimeframe: From week 30 to 36
- Proportion of subjects whose mean hemoglobin level is below the target rangeTimeframe: From week 30 to 36
- Proportion of subjects with hemoglobin levels in the target rangeTimeframe: Up to 52 weeks
- Proportion of subjects with hemoglobin levels above the target rangeTimeframe: Up to 52 weeks
- Proportion of subjects with hemoglobin levels below the target rangeTimeframe: Up to 52 weeks
- Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/weekDefined as change in Hb level / duration between two visits (weeks)Timeframe: Up to 52 weeks
- Number of participants with serious adverse eventsTimeframe: Up to 52 weeks
- Maximum concentration (Cmax)Timeframe: At baseline, week 12, week 24 and week 52
- Area under the concentration-time curve (AUC)Timeframe: At baseline, week 12, week 24 and week 52
- EPO (Erythropoietin) serum concentrationTimeframe: At baseline, week 12, week 24 and week 52
Additional Information
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