AnemiaPhase 3MIYABI ND-CNCT03350321

A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects

A Phase 3 study testing Molidustat (BAY85-3934) and Darbepoetin alfa in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 61 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). 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) and Darbepoetin alfa
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 61 sitesJapan
Study dates: 12 Dec 2017to 11 Oct 2019
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

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

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

61 sites in 1 country.

City, postcode or hospital

61 sites in 1 country

Japan61 sites

Mazda Hospital of Mazda Motor Corporation
Aki-gun, Hiroshima, 735-8585
Arao Municipal Hospital
Arao, Kumamoto, 864-0041
University of Yamanashi Hospital
Chūō, Yamanashi, 409-3898
Fujisawa City Hospital
Fujisawa, Kanagawa, 251-8550
Fukui Prefectural Hospital
Fukui, 910-8526
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
Kyushu University Hospital
Fukuoka, 812-8582
Fukuoka University Hospital
Fukuoka, 814-0180
Fukushima Medical University Hospital
Fukushima, 960-1295
Nippon Kokan Fukuyama Hospital
Fukuyama, Hiroshima, 721-0927
Asahi University Hospital
Gifu, 500-8523
Matsunami Health Promotion Clinic
Hashima-gun, Gifu, 501-6061
National hospital Organization Mito Medical Center
Higashiibaraki, Ibaraki, 311-3193
Iizuka Hospital
Iizuka, Fukuoka, 820-8505
Japanese Red Cross Ishinomaki Hospital
Ishinomaki, Miyagi, 986-8522
Iwata City Hospital
Iwata, Shizuoka, 438-8550
Ikeda Hospital
Kanoya, Kagoshima-ken, 893-0024
Koukan Clinic
Kawasaki, Kanagawa, 210-0852
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, 805-8508
Kitasato University Medical Center
Kitamoto, Saitama, 364-8501
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
National Hospital Organization Kobe Medical Center
Kobe, Hyōgo, 654-0155
National Hospital Organization Kochi National Hospital
Kochi, 780-8077
National Fukuoka-Higashi Medical Center
Koga, Fukuoka, 811-3195
Asama Nanroku Komoro Medical Center
Komoro, Nagano, 384-8588
Showa University Koto Toyosu Hospital
Koto-ku, Tokyo, 135-8577
Kurume University Hospital
Kurume, Fukuoka, 830-0011
St.Mary's Hospital
Kurume, Fukuoka, 830-8543
Seikeikai New Tokyo Heart Clinic
Matsudo, Chiba, 271-0077
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, 791-8026
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015
Nara Prefecture General Medical Center
Nara, 630-8581
Japanese Red Cross Oita Hospital
Ōita, 870-0033
Kitano Hospital
Osaka, 530-8480
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
Osaka Red Cross Hospital
Osaka, 543-8555
Nippon Life Hospital
Osaka, 550-0006
Chibune Clinic
Osaka, 555-0001
Osaka General Medical Center
Osaka, 558-8558
Social Corporation Keigakukai Minamiosaka Hospital
Osaka, 559-0012
Teine Keijinkai Clinic
Sapporo, Hokkaido, 006-8555
Niigata Prefectural Shibata Hospital
Shibata, Niigata, 957-8588
Shizuoka Saiseikai General Hospital
Shizuoka, 422-8527
Suruga Clinic
Shizuoka, 424-0855
Osaka Saiseikai Senri Hospital
Suita, Osaka, 565-0862
Toshima Hospital
tabashi City, Tokyo, 173-0015
Nihon University Itabashi Hospital
tabashi City, Tokyo, 173-8610
Gifu Prefectural Tajimi Hospital
Tajimi, Gifu, 507-8522
KenAiKai medical corporation Akiyama clinic
Takamatsu, Kagawa-ken, 761-1701
Osaka Pref. Saiseikai Tondabayashi Hospital
Tondabayashi, Osaka, 584-0082
Uji-Tokushukai Medical Center
Uji, Kyoto, 611-0041
Okinawa prefectural Chubu Hospital
Uruma, Okinawa, 904-2293
Wakayama Medical University Hospital
Wakayama, 641-8510
Kainan Hospital
Yatomi, Aichi-ken, 498-8502
Kumamoto Rosai Hospital
Yatsushiro, Kumamoto, 866-8533
JCHO Yokkaichi Hazu Medical Center
Yokkaichi, Mie-ken, 510-0016
Showa University Fujigaoka Hospital
Yokohama, Kanagawa, 227-8501
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, 238-8558

Other trials in Japan

About this study

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)

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).

Conditions: Anemia, Renal Insufficiency, Chronic
Being tested: Molidustat (BAY85-3934), Darbepoetin alfa
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
Darbepoetin alfaDrug
Starting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) response

Study groups in NCT03350321
Study group	Role	What they receive
Molidustat (BAY85-3934)	Experimental	Molidustat group Receives: Drug: Molidustat (BAY85-3934)
Darbepoetin alfa	Active comparator	Darbepoetin alfa group Receives: Drug: Darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Hb (Hemoglobin) level
Measured: From week 30 to 36
Change in hemoglobin level from baseline to the average during the evaluation period
Measured: Baseline and week 30 to 36

Secondary outcomes (18)

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: From week 30 to 36
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Measured: Up to 8 weeks
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: From week 30 to 36
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once
Measured: Up to 52 weeks
Change in Hb level
Measured: Baseline and up to 52 weeks
Hb level
Measured: Baseline and up to 52 weeks
Proportion of subjects whose mean hemoglobin level is in the target range
Measured: From week 30 to 36
Proportion of subjects whose mean hemoglobin level is above the target range
Measured: From week 30 to 36
Proportion of subjects whose mean hemoglobin level is below the target range
Measured: From week 30 to 36
Proportion of subjects with hemoglobin levels in the target range
Measured: Up to 52 weeks
Proportion of subjects with hemoglobin levels above the target range
Measured: Up to 52 weeks
Proportion of subjects with hemoglobin levels below the target range
Measured: 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)
Measured: Up to 52 weeks
Number of participants with serious adverse events
Measured: Up to 52 weeks
Maximum concentration (Cmax)
Measured: At baseline, week 12, week 24 and week 52
Area under the concentration-time curve (AUC)
Measured: At baseline, week 12, week 24 and week 52
EPO (Erythropoietin) serum concentration
Measured: At baseline, week 12, week 24 and week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201711 Oct 2019

First posted22 Nov 2017
Study start12 Dec 2017
Primary completion17 May 2019
Study completion11 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03350321
Sponsor's protocol ID: 19349
Acronym: MIYABI ND-C
Status last verified: Jan 2021
First submitted: 19 Nov 2017
Last updated: 29 Jan 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37095342
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.
PubMed 36005278
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.
PubMed 31203242

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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 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)
ClinicalTrials.gov ID: NCT03350321
Acronym / sponsor ID: MIYABI ND-C / 19349
Conditions: Anemia, Renal Insufficiency, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 12 Dec 2017 (actual)
Primary completion: 17 May 2019 (actual)
Study completion: 11 Oct 2019 (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 non-dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Molidustat (BAY85-3934)	Experimental	Drug: Molidustat (BAY85-3934)Molidustat group
Darbepoetin alfa	Active comparator	Drug: Darbepoetin alfaDarbepoetin alfa 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)

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

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)
Darbepoetin alfaStarting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) response	Drug	Darbepoetin alfa

Primary outcome

Mean Hb (Hemoglobin) level
Time frame: From week 30 to 36
Change in hemoglobin level from baseline to the average during the evaluation period
Time frame: Baseline and week 30 to 36

18 secondary outcomes

Responder rate: proportion of responders among the subjects
Time frame: From week 30 to 36
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time frame: Up to 8 weeks
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: From week 30 to 36
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once
Time frame: Up to 52 weeks
Change in Hb level
Time frame: Baseline and up to 52 weeks
Hb level
Time frame: Baseline and up to 52 weeks
Proportion of subjects whose mean hemoglobin level is in the target range
Time frame: From week 30 to 36
Proportion of subjects whose mean hemoglobin level is above the target range
Time frame: From week 30 to 36
Proportion of subjects whose mean hemoglobin level is below the target range
Time frame: From week 30 to 36
Proportion of subjects with hemoglobin levels in the target range
Time frame: Up to 52 weeks
Proportion of subjects with hemoglobin levels above the target range
Time frame: Up to 52 weeks
Proportion of subjects with hemoglobin levels below the target range
Time frame: Up to 52 weeks
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week
Time frame: Up to 52 weeks
Number of participants with serious adverse events
Time frame: Up to 52 weeks
Maximum concentration (Cmax)
Time frame: At baseline, week 12, week 24 and week 52
Area under the concentration-time curve (AUC)
Time frame: At baseline, week 12, week 24 and week 52
EPO (Erythropoietin) serum concentration
Time frame: At baseline, week 12, week 24 and week 52

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 37095342Yamamoto 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.
Derived from this study: PubMed 36005278Natale 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.
Derived from this study: PubMed 31203242Yamamoto 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.

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Not yet recruitingObservational study
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RecruitingObservational study
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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.

61 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) and Darbepoetin alfa in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 61 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 61 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?

Mean Hb (Hemoglobin) level (time frame: From week 30 to 36). 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 NCT03350321, which also lists 3 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.