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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molidustat (BAY85-3934) | Experimental | Molidustat group |
|
| Darbepoetin alfa | Active Comparator | Darbepoetin alfa group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molidustat (BAY85-3934) | Drug | Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hb (Hemoglobin) level | From week 30 to 36 | |
| Change in hemoglobin level from baseline to the average during the evaluation period | Baseline and week 30 to 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate: proportion of responders among the subjects | Responder 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 treatment | From week 30 to 36 |
| Rate of rise in Hb (Hemoglobin) level (g/dL/week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kainan Hospital | Yatomi | Aichi-ken | 498-8502 | Japan | ||
| Seikeikai New Tokyo Heart Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37095342 | Derived | Yamamoto H, Yamada T, Miyazaki K, Yamashita T, Kato T, Ohara K, Nakamura Y, Akizawa T. Treatment satisfaction with molidustat in CKD-related anemia in non-dialysis patients: a post-hoc analysis of two clinical trials. Clin Exp Nephrol. 2023 Aug;27(8):651-659. doi: 10.1007/s10157-023-02353-x. Epub 2023 Apr 24. | |
| 36005278 | Derived |
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| Darbepoetin alfa | Drug | Starting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) response |
|
| Up to 8 weeks |
| Rate of rise in Hb (Hemoglobin) level (g/dL/week) | Up to 4 weeks |
| Proportion of subjects who meet each component of the response | Response: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment | From week 30 to 36 |
| Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once | Up to 52 weeks |
| Change in Hb level | Baseline and up to 52 weeks |
| Hb level | Baseline and up to 52 weeks |
| Proportion of subjects whose mean hemoglobin level is in the target range | From week 30 to 36 |
| Proportion of subjects whose mean hemoglobin level is above the target range | From week 30 to 36 |
| Proportion of subjects whose mean hemoglobin level is below the target range | From week 30 to 36 |
| Proportion of subjects with hemoglobin levels in the target range | Up to 52 weeks |
| Proportion of subjects with hemoglobin levels above the target range | Up to 52 weeks |
| Proportion of subjects with hemoglobin levels below the target range | Up to 52 weeks |
| Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week | Defined as change in Hb level / duration between two visits (weeks) | Up to 52 weeks |
| Number of participants with serious adverse events | Up to 52 weeks |
| Maximum concentration (Cmax) | At baseline, week 12, week 24 and week 52 |
| Area under the concentration-time curve (AUC) | At baseline, week 12, week 24 and week 52 |
| EPO (Erythropoietin) serum concentration | At baseline, week 12, week 24 and week 52 |
| Matsudo |
| Chiba |
| 271-0077 |
| Japan |
| Ehime Prefectural Central Hospital | Matsuyama | Ehime | 790-0024 | Japan |
| Saiseikai Matsuyama Hospital | Matsuyama | Ehime | 791-8026 | Japan |
| Iizuka Hospital | Iizuka | Fukuoka | 820-8505 | Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 802-8555 | Japan |
| Steel Memorial Yawata Hospital | Kitakyushu | Fukuoka | 805-8508 | Japan |
| National Fukuoka-Higashi Medical Center | Koga | Fukuoka | 811-3195 | Japan |
| Kurume University Hospital | Kurume | Fukuoka | 830-0011 | Japan |
| St.Mary's Hospital | Kurume | Fukuoka | 830-8543 | Japan |
| Matsunami Health Promotion Clinic | Hashima-gun | Gifu | 501-6061 | Japan |
| Gifu Prefectural Tajimi Hospital | Tajimi | Gifu | 507-8522 | Japan |
| Mazda Hospital of Mazda Motor Corporation | Aki-gun | Hiroshima | 735-8585 | Japan |
| Nippon Kokan Fukuyama Hospital | Fukuyama | Hiroshima | 721-0927 | Japan |
| Teine Keijinkai Clinic | Sapporo | Hokkaido | 006-8555 | Japan |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | 650-0047 | Japan |
| National Hospital Organization Kobe Medical Center | Kobe | Hyōgo | 654-0155 | Japan |
| National hospital Organization Mito Medical Center | Higashiibaraki | Ibaraki | 311-3193 | Japan |
| Mito Kyodo General Hospital | Mito | Ibaraki | 310-0015 | Japan |
| KenAiKai medical corporation Akiyama clinic | Takamatsu | Kagawa-ken | 761-1701 | Japan |
| Ikeda Hospital | Kanoya | Kagoshima-ken | 893-0024 | Japan |
| Fujisawa City Hospital | Fujisawa | Kanagawa | 251-8550 | Japan |
| Koukan Clinic | Kawasaki | Kanagawa | 210-0852 | Japan |
| Showa University Fujigaoka Hospital | Yokohama | Kanagawa | 227-8501 | Japan |
| Yokosuka Kyosai Hospital | Yokosuka | Kanagawa | 238-8558 | Japan |
| Arao Municipal Hospital | Arao | Kumamoto | 864-0041 | Japan |
| Kumamoto Rosai Hospital | Yatsushiro | Kumamoto | 866-8533 | Japan |
| Uji-Tokushukai Medical Center | Uji | Kyoto | 611-0041 | Japan |
| JCHO Yokkaichi Hazu Medical Center | Yokkaichi | Mie-ken | 510-0016 | Japan |
| Japanese Red Cross Ishinomaki Hospital | Ishinomaki | Miyagi | 986-8522 | Japan |
| Asama Nanroku Komoro Medical Center | Komoro | Nagano | 384-8588 | Japan |
| Niigata Prefectural Shibata Hospital | Shibata | Niigata | 957-8588 | Japan |
| Okinawa prefectural Chubu Hospital | Uruma | Okinawa | 904-2293 | Japan |
| Osaka Saiseikai Senri Hospital | Suita | Osaka | 565-0862 | Japan |
| Osaka Pref. Saiseikai Tondabayashi Hospital | Tondabayashi | Osaka | 584-0082 | Japan |
| Kitasato University Medical Center | Kitamoto | Saitama | 364-8501 | Japan |
| Iwata City Hospital | Iwata | Shizuoka | 438-8550 | Japan |
| Toshima Hospital | Itabashi-ku | Tokyo | 173-0015 | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku | Tokyo | 173-8610 | Japan |
| Showa University Koto Toyosu Hospital | Koto-ku | Tokyo | 135-8577 | Japan |
| National Hospital Organization Tokyo Medical Center | Meguro-ku | Tokyo | 152-8902 | Japan |
| University of Yamanashi Hospital | Chūō | Yamanashi | 409-3898 | Japan |
| Fukui Prefectural Hospital | Fukui | 910-8526 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Asahi University Hospital | Gifu | 500-8523 | Japan |
| National Hospital Organization Kochi National Hospital | Kochi | 780-8077 | Japan |
| Nara Prefecture General Medical Center | Nara | 630-8581 | Japan |
| Kitano Hospital | Osaka | 530-8480 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| Osaka Red Cross Hospital | Osaka | 543-8555 | Japan |
| Nippon Life Hospital | Osaka | 550-0006 | Japan |
| Chibune Clinic | Osaka | 555-0001 | Japan |
| Osaka General Medical Center | Osaka | 558-8558 | Japan |
| Social Corporation Keigakukai Minamiosaka Hospital | Osaka | 559-0012 | Japan |
| Japanese Red Cross Oita Hospital | Ōita | 870-0033 | Japan |
| Shizuoka Saiseikai General Hospital | Shizuoka | 422-8527 | Japan |
| Suruga Clinic | Shizuoka | 424-0855 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641-8510 | Japan |
| Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. |
| 31203242 | Derived | Yamamoto H, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Akizawa T. Molidustat for the treatment of renal anaemia in patients with non-dialysis-dependent chronic kidney disease: design and rationale of two phase III studies. BMJ Open. 2019 Jun 14;9(6):e026704. doi: 10.1136/bmjopen-2018-026704. |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000603972 | molidustat |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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