Back to resultsA Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects (MIYABI ND-C)
Primary Purpose
Anemia, Renal Insufficiency, Chronic
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Molidustat (BAY85-3934)
Darbepoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
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)
Sites / Locations
- Kainan Hospital
- Seikeikai New Tokyo Heart Clinic
- Ehime Prefectural Central Hospital
- Saiseikai Matsuyama Hospital
- Iizuka Hospital
- Kokura Memorial Hospital
- Steel Memorial Yawata Hospital
- National Fukuoka-Higashi Medical Center
- Kurume University Hospital
- St.Mary's Hospital
- Matsunami Health Promotion Clinic
- Gifu Prefectural Tajimi Hospital
- Mazda Hospital of Mazda Motor Corporation
- Nippon Kokan Fukuyama Hospital
- Teine Keijinkai Clinic
- Kobe City Medical Center General Hospital
- National Hospital Organization Kobe Medical Center
- National hospital Organization Mito Medical Center
- Mito Kyodo General Hospital
- KenAiKai medical corporation Akiyama clinic
- Ikeda Hospital
- Fujisawa City Hospital
- Koukan Clinic
- Showa University Fujigaoka Hospital
- Yokosuka Kyosai Hospital
- Arao Municipal Hospital
- Kumamoto Rosai Hospital
- Uji-Tokushukai Medical Center
- JCHO Yokkaichi Hazu Medical Center
- Japanese Red Cross Ishinomaki Hospital
- Asama Nanroku Komoro Medical Center
- Niigata Prefectural Shibata Hospital
- Okinawa prefectural Chubu Hospital
- Osaka Saiseikai Senri Hospital
- Osaka Pref. Saiseikai Tondabayashi Hospital
- Kitasato University Medical Center
- Iwata City Hospital
- Toshima Hospital
- Nihon University Itabashi Hospital
- Showa University Koto Toyosu Hospital
- National Hospital Organization Tokyo Medical Center
- University of Yamanashi Hospital
- Fukui Prefectural Hospital
- National Hospital Organization Kyushu Medical Center
- Kyushu University Hospital
- Fukuoka University Hospital
- Fukushima Medical University Hospital
- Asahi University Hospital
- National Hospital Organization Kochi National Hospital
- Nara Prefecture General Medical Center
- Japanese Red Cross Oita Hospital
- Kitano Hospital
- National Hospital Organization Osaka National Hospital
- Osaka Red Cross Hospital
- Nippon Life Hospital
- Chibune Clinic
- Osaka General Medical Center
- Social Corporation Keigakukai Minamiosaka Hospital
- Shizuoka Saiseikai General Hospital
- Suruga Clinic
- Wakayama Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Molidustat (BAY85-3934)
Darbepoetin alfa
Arm Description
Molidustat group
Darbepoetin alfa group
Outcomes
Primary Outcome Measures
Mean Hb (Hemoglobin) level
Change in hemoglobin level from baseline to the average during the evaluation period
Secondary Outcome Measures
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
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
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
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once
Change in Hb level
Hb level
Proportion of subjects whose mean hemoglobin level is in the target range
Proportion of subjects whose mean hemoglobin level is above the target range
Proportion of subjects whose mean hemoglobin level is below the target range
Proportion of subjects with hemoglobin levels in the target range
Proportion of subjects with hemoglobin levels above the target range
Proportion of subjects with hemoglobin levels below the target range
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)
Number of participants with serious adverse events
Maximum concentration (Cmax)
Area under the concentration-time curve (AUC)
EPO (Erythropoietin) serum concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03350321
Brief Title
A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects
Acronym
MIYABI ND-C
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
October 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Renal Insufficiency, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Molidustat (BAY85-3934)
Arm Type
Experimental
Arm Description
Molidustat group
Arm Title
Darbepoetin alfa
Arm Type
Active Comparator
Arm Description
Darbepoetin alfa group
Intervention Type
Drug
Intervention Name(s)
Molidustat (BAY85-3934)
Intervention Description
Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Intervention Description
Starting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) response
Primary Outcome Measure Information:
Title
Mean Hb (Hemoglobin) level
Time Frame
From week 30 to 36
Title
Change in hemoglobin level from baseline to the average during the evaluation period
Time Frame
Baseline and week 30 to 36
Secondary Outcome Measure Information:
Title
Responder rate: proportion of responders among the subjects
Description
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
Time Frame
From week 30 to 36
Title
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time Frame
Up to 8 weeks
Title
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time Frame
Up to 4 weeks
Title
Proportion of subjects who meet each component of the response
Description
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
Time Frame
From week 30 to 36
Title
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once
Time Frame
Up to 52 weeks
Title
Change in Hb level
Time Frame
Baseline and up to 52 weeks
Title
Hb level
Time Frame
Baseline and up to 52 weeks
Title
Proportion of subjects whose mean hemoglobin level is in the target range
Time Frame
From week 30 to 36
Title
Proportion of subjects whose mean hemoglobin level is above the target range
Time Frame
From week 30 to 36
Title
Proportion of subjects whose mean hemoglobin level is below the target range
Time Frame
From week 30 to 36
Title
Proportion of subjects with hemoglobin levels in the target range
Time Frame
Up to 52 weeks
Title
Proportion of subjects with hemoglobin levels above the target range
Time Frame
Up to 52 weeks
Title
Proportion of subjects with hemoglobin levels below the target range
Time Frame
Up to 52 weeks
Title
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week
Description
Defined as change in Hb level / duration between two visits (weeks)
Time Frame
Up to 52 weeks
Title
Number of participants with serious adverse events
Time Frame
Up to 52 weeks
Title
Maximum concentration (Cmax)
Time Frame
At baseline, week 12, week 24 and week 52
Title
Area under the concentration-time curve (AUC)
Time Frame
At baseline, week 12, week 24 and week 52
Title
EPO (Erythropoietin) serum concentration
Time Frame
At baseline, week 12, week 24 and week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Kainan Hospital
City
Yatomi
State/Province
Aichi
ZIP/Postal Code
498-8502
Country
Japan
Facility Name
Seikeikai New Tokyo Heart Clinic
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
271-0077
Country
Japan
Facility Name
Ehime Prefectural Central Hospital
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Saiseikai Matsuyama Hospital
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-8026
Country
Japan
Facility Name
Iizuka Hospital
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Facility Name
Steel Memorial Yawata Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
805-8508
Country
Japan
Facility Name
National Fukuoka-Higashi Medical Center
City
Koga
State/Province
Fukuoka
ZIP/Postal Code
811-3195
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
St.Mary's Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-8543
Country
Japan
Facility Name
Matsunami Health Promotion Clinic
City
Hashima-gun
State/Province
Gifu
ZIP/Postal Code
501-6061
Country
Japan
Facility Name
Gifu Prefectural Tajimi Hospital
City
Tajimi
State/Province
Gifu
ZIP/Postal Code
507-8522
Country
Japan
Facility Name
Mazda Hospital of Mazda Motor Corporation
City
Aki-gun
State/Province
Hiroshima
ZIP/Postal Code
735-8585
Country
Japan
Facility Name
Nippon Kokan Fukuyama Hospital
City
Fukuyama
State/Province
Hiroshima
ZIP/Postal Code
721-0927
Country
Japan
Facility Name
Teine Keijinkai Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Hospital Organization Kobe Medical Center
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
654-0155
Country
Japan
Facility Name
National hospital Organization Mito Medical Center
City
Higashiibaraki
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Mito Kyodo General Hospital
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0015
Country
Japan
Facility Name
KenAiKai medical corporation Akiyama clinic
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
761-1701
Country
Japan
Facility Name
Ikeda Hospital
City
Kanoya
State/Province
Kagoshima
ZIP/Postal Code
893-0024
Country
Japan
Facility Name
Fujisawa City Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
Koukan Clinic
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
227-8501
Country
Japan
Facility Name
Yokosuka Kyosai Hospital
City
Yokosuka
State/Province
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
Arao Municipal Hospital
City
Arao
State/Province
Kumamoto
ZIP/Postal Code
864-0041
Country
Japan
Facility Name
Kumamoto Rosai Hospital
City
Yatsushiro
State/Province
Kumamoto
ZIP/Postal Code
866-8533
Country
Japan
Facility Name
Uji-Tokushukai Medical Center
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0041
Country
Japan
Facility Name
JCHO Yokkaichi Hazu Medical Center
City
Yokkaichi
State/Province
Mie
ZIP/Postal Code
510-0016
Country
Japan
Facility Name
Japanese Red Cross Ishinomaki Hospital
City
Ishinomaki
State/Province
Miyagi
ZIP/Postal Code
986-8522
Country
Japan
Facility Name
Asama Nanroku Komoro Medical Center
City
Komoro
State/Province
Nagano
ZIP/Postal Code
384-8588
Country
Japan
Facility Name
Niigata Prefectural Shibata Hospital
City
Shibata
State/Province
Niigata
ZIP/Postal Code
957-8588
Country
Japan
Facility Name
Okinawa prefectural Chubu Hospital
City
Uruma
State/Province
Okinawa
ZIP/Postal Code
904-2293
Country
Japan
Facility Name
Osaka Saiseikai Senri Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0862
Country
Japan
Facility Name
Osaka Pref. Saiseikai Tondabayashi Hospital
City
Tondabayashi
State/Province
Osaka
ZIP/Postal Code
584-0082
Country
Japan
Facility Name
Kitasato University Medical Center
City
Kitamoto
State/Province
Saitama
ZIP/Postal Code
364-8501
Country
Japan
Facility Name
Iwata City Hospital
City
Iwata
State/Province
Shizuoka
ZIP/Postal Code
438-8550
Country
Japan
Facility Name
Toshima Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-0015
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Showa University Koto Toyosu Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8577
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
University of Yamanashi Hospital
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
Fukui Prefectural Hospital
City
Fukui
ZIP/Postal Code
910-8526
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Asahi University Hospital
City
Gifu
ZIP/Postal Code
500-8523
Country
Japan
Facility Name
National Hospital Organization Kochi National Hospital
City
Kochi
ZIP/Postal Code
780-8077
Country
Japan
Facility Name
Nara Prefecture General Medical Center
City
Nara
ZIP/Postal Code
630-8581
Country
Japan
Facility Name
Japanese Red Cross Oita Hospital
City
Oita
ZIP/Postal Code
870-0033
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka Red Cross Hospital
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Nippon Life Hospital
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Facility Name
Chibune Clinic
City
Osaka
ZIP/Postal Code
555-0001
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Social Corporation Keigakukai Minamiosaka Hospital
City
Osaka
ZIP/Postal Code
559-0012
Country
Japan
Facility Name
Shizuoka Saiseikai General Hospital
City
Shizuoka
ZIP/Postal Code
422-8527
Country
Japan
Facility Name
Suruga Clinic
City
Shizuoka
ZIP/Postal Code
424-0855
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
36005278
Citation
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.
Results Reference
derived
PubMed Identifier
31203242
Citation
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.
Results Reference
derived
Links:
URL
http://clinicaltrials.bayer.com/
Description
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Learn more about this trial
A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects
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