AzTrials
AzTrials

AnemiaPhase 3MIYABI ND-MNCT03350347

A Study of Molidustat for Maintenance Treatment 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 59 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 previously 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
164 participants
Where
59 sitesJapan
Study dates
13 Dec 2017to 28 Nov 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)
  • Have used the same ESA for 8 weeks prior to screening
  • Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization
  • 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
  • Mean screening Hb level ≥ 10.0 and < 13.0 g/dL (mean of all central laboratory Hb levels [at least 2 measurements must be taken ≥ 2 days apart] during the 8-week screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is < 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization
  • Ferritin ≥ 100 ng/mL or Transferrin saturation ≥ 20%

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 (blood pressure)≥ 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

59 sites in 1 country.

59 sites in 1 country

Japan59 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

  • Nippon Kokan Fukuyama Hospital

    Fukuyama, Hiroshima, 721-0927

  • Asahi University Hospital

    Gifu, 500-8523

  • Public Central Hospital of Matto Ishikawa

    Hakusan, Ishikawa-ken, 924-8588

  • Matsunami Health Promotion Clinic

    Hashima-gun, Gifu, 501-6061

  • Higashihiroshima Medical Center

    Higashihiroshima, Hiroshima, 739-0041

  • 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

  • Miyazaki Prefectural Miyazaki Hospital

    Miyazaki, 880-8510

  • R.I.A.C Naha City Hospital

    Naha, Okinawa, 902-8511

  • Nara Prefecture General Medical Center

    Nara, 630-8581

  • Japanese Red Cross Oita Hospital

    Ōita, 870-0033

  • Kitano Hospital

    Osaka, 530-8480

  • Yodogawa Christian Hospital

    Osaka, 533-0024

  • 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

  • Toshima Hospital

    tabashi City, Tokyo, 173-0015

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • KenAiKai medical corporation Akiyama clinic

    Takamatsu, Kagawa-ken, 761-1701

  • Osaka Pref. Saiseikai Tondabayashi Hospital

    Tondabayashi, Osaka, 584-0082

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

  • Kainan Hospital

    Yatomi, Aichi-ken, 498-8502

  • 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 Previously Treated With Erythropoiesis-Stimulating Agents (ESAs)

The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)

Being tested
Molidustat (BAY85-3934), Darbepoetin alfa
Keywords
Renal anemia
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 25 mg or 50 mg molidustat once daily (OD) will be titrated based on the subject's Hb response

  • Darbepoetin alfaDrug

    Starting dose and frequency of darbepoetin alfa are based on previous ESA. The dose will be titrated based on the subject's Hb response

Study groups in NCT03350347
Study groupRoleWhat they receive
Molidustat (BAY85-3934)ExperimentalMolidustat group
Receives: Drug: Molidustat (BAY85-3934)
Darbepoetin alfaActive comparatorDarbepoetin alfa group
Receives: Drug: Darbepoetin alfa

What is being measured

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

  1. Mean Hb (Hemoglobin) level

    Measured: From week 30 to 36

  2. Change in hemoglobin level from baseline to the average during the evaluation period

    Measured: Baseline and week 30 to 36

Secondary outcomes (15)

  1. 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

  2. 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

  3. Hb level

    Measured: Baseline and up to 52 weeks

  4. Change in Hb level

    Measured: Baseline and up to 52 weeks

  5. Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period

    Measured: From week 30 to 36

  6. Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period

    Measured: From week 30 to 36

  7. Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period

    Measured: From week 30 to 36

  8. Proportion of subjects whose hemoglobin levels are in the target range

    Measured: Up to 52 weeks

  9. Proportion of subjects whose hemoglobin levels are above the target range

    Measured: Up to 52 weeks

  10. Proportion of subjects whose hemoglobin levels are below the target range

    Measured: Up to 52 weeks

  11. 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

  12. Number of participants with serious adverse events

    Measured: Up to 52 weeks

  13. Maximum concentration (Cmax) of Molidustat

    Measured: At baseline, week 12, week 24 and week 52

  14. Area under the concentration-time curve (AUC) of Molidustat

    Measured: At baseline, week 12, week 24 and week 52

  15. EPO (Erythropoietin) serum concentration of Molidustat

    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.

  1. First posted22 Nov 2017
  2. Study start13 Dec 2017
  3. Primary completion5 Jul 2019
  4. Study completion28 Nov 2019

Resources

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
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350347
Sponsor's protocol ID
19350
Acronym
MIYABI ND-M
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

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 59 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 8 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 59 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 NCT03350347, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in