AnemiaPhase 3MIYABI HD-CNCT03351166
A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects
A Phase 3 study testing Molidustat (BAY85-3934) in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 20 sites in Japan.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anemia, Renal Insufficiency, Chronic
- What is being tested?
- Molidustat (BAY85-3934)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 20 sitesJapan
- Study dates
- 22 Jan 2018to 20 Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Asahikawa-Kosei General Hospital
Asahikawa, Hokkaido, 078-8211
Medical corporation association Shunshin-kai Inage hospital
Chiba, 263-0043
Fukuoka Renal Clinic
Fukuoka, 810-0004
Matsunami General Hospital
Hashima-gun, Gifu, 501-6062
Iida Hospital
Iida, Nagano, 395-8505
Ishikari Hospital
Ishikari, Hokkaido, 061-3213
Japanese Red Cross Ishinomaki Hospital
Ishinomaki, Miyagi, 986-8522
Houshikai Kano hospital
Kasuya-gun, Fukuoka, 811-0120
Kodaira Kitaguchi Clinic
Kodaira, Tokyo, 187-0001
Japanese Red Cross Koga Hospital
Koga, Ibaraki, 306-0014
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015
Itami Kidney Clinic
Noboribetsu, Hokkaido, 059-0026
Ohmiya Chuo General Hospital
Saitama, 331-8711
Souen Central Hospital
Sapporo, Hokkaido, 060-0008
Takasago Seibu Hospital
Takasago, Hyōgo, 676-0812
Tokiwa Clinic
Totte, Ibaraki, 302-0011
Toyonaka Keijinkai Clinic
Toyonaka, Osaka, 560-0004
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, 300-0062
Kikuchi Medical Clinic
Tsukuba, Ibaraki, 305-0861
Yamagata Tokushukai Hospital
Yamagata, 990-0834
About this study
Official title: A Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)
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)
- Conditions
- Anemia, Renal Insufficiency, Chronic
- Being tested
- Molidustat (BAY85-3934)
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molidustat (BAY85-3934)Drug
Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
| Study group | Role | What they receive |
|---|---|---|
| Molidustat (BAY85-3934) | Experimental | Molidustat group Receives: Drug: Molidustat (BAY85-3934) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Measured: Up to 8 weeks
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
Measured: Week 21 to 24
Secondary outcomes (16)
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Measured: 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
Measured: Week 21 to 24
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit
Measured: Up to 24 weeks
Hb level
Measured: Baseline and up to 24 weeks
Change in Hb level
Measured: Baseline and up to 24 weeks
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period
Measured: Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period
Measured: Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
Measured: Week 21 to 24
Proportion of subjects with hemoglobin levels above the target range
Measured: Up to 24 weeks
Proportion of subjects with hemoglobin levels below the target range
Measured: Up to 24 weeks
Proportion of subjects with hemoglobin levels in the target range
Measured: Up to 24 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)
Measured: Up to 24 weeks
Number of participants with serious adverse events
Measured: Up to 24 weeks
Maximum concentration (Cmax) of Molidustat
Measured: Baseline, Week 8, Week16 and Week 24
Area under the concentration-time curve (AUC) of Molidustat
Measured: Baseline, Week 8, Week16 and Week 24
EPO (Erythropoietin) serum concentration of Molidustat
Measured: Baseline, Week 8, Week16 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start22 Jan 2018
- Primary completion23 Oct 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351166
- Sponsor's protocol ID
- 19351
- Acronym
- MIYABI HD-C
- Status last verified
- Jan 2021
- First submitted
- 20 Nov 2017
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akizawa T, Nobori K, Matsuda Y, Hayashi Y, Hayasaki T, Yamamoto H. Molidustat for anemia correction in Japanese patients undergoing hemodialysis: a single-arm, phase 3 study. Ther Apher Dial. 2021 Dec;25(6):917-925. doi: 10.1111/1744-9987.13627. Epub 2021 Mar 22.
PubMed 33506635Akizawa T, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Yamamoto H. Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies. BMJ Open. 2019 Jun 14;9(6):e026602. doi: 10.1136/bmjopen-2018-026602.
PubMed 31203241
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)
- ClinicalTrials.gov ID
- NCT03351166
- Acronym / sponsor ID
- MIYABI HD-C / 19351
- Conditions
- Anemia, Renal Insufficiency, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molidustat (BAY85-3934) | Experimental | Drug: Molidustat (BAY85-3934)Molidustat group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molidustat (BAY85-3934)Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response | Drug | Molidustat (BAY85-3934) |
Primary outcome
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time frame: Up to 8 weeks
Responder rate: proportion of responders among the subjects
Time frame: Week 21 to 24
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
16 secondary outcomes
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time frame: Up to 4 weeks
Proportion of subjects who meet each component of the response
Time frame: Week 21 to 24
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit
Time frame: Up to 24 weeks
Hb level
Time frame: Baseline and up to 24 weeks
Change in Hb level
Time frame: Baseline and up to 24 weeks
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period
Time frame: Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period
Time frame: Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
Time frame: Week 21 to 24
Proportion of subjects with hemoglobin levels above the target range
Time frame: Up to 24 weeks
Proportion of subjects with hemoglobin levels below the target range
Time frame: Up to 24 weeks
Proportion of subjects with hemoglobin levels in the target range
Time frame: Up to 24 weeks
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week
Time frame: Up to 24 weeks
Number of participants with serious adverse events
Time frame: Up to 24 weeks
Maximum concentration (Cmax) of Molidustat
Time frame: Baseline, Week 8, Week16 and Week 24
Area under the concentration-time curve (AUC) of Molidustat
Time frame: Baseline, Week 8, Week16 and Week 24
EPO (Erythropoietin) serum concentration of Molidustat
Time frame: Baseline, Week 8, Week16 and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 33506635Akizawa T, Nobori K, Matsuda Y, Hayashi Y, Hayasaki T, Yamamoto H. Molidustat for anemia correction in Japanese patients undergoing hemodialysis: a single-arm, phase 3 study. Ther Apher Dial. 2021 Dec;25(6):917-925. doi: 10.1111/1744-9987.13627. Epub 2021 Mar 22.
- Derived from this study: PubMed 31203241Akizawa T, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Yamamoto H. Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies. BMJ Open. 2019 Jun 14;9(6):e026602. doi: 10.1136/bmjopen-2018-026602.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Molidustat (BAY85-3934) in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of rise in Hb (Hemoglobin) level (g/dL/week) (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03351166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.