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AnemiaPhase 3MIYABI HD-MNCT03543657

Maintenance Treatment of Renal Anemia in 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 53 sites in Japan.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are 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?
Yes, some participants may receive a placebo
How many people
229 participants
Where
53 sitesJapan
Study dates
23 Jun 2018to 24 Dec 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

  • Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization
  • Body weight (after dialysis) > 40 and ≤ 160 kg at screening
  • Male or female subject ≥ 20 years of age at screening
  • At least one kidney
  • Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization
  • Mean screening Hb level ≥ 9.5 and < 12.0 g/dL (mean of all central laboratory Hb levels before dialysis [at least 2 measurements must be taken ≥ 2 days apart] during the 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% at screening
  • Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) 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, 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 agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

Japan53 sites

  • Asahikawa-Kosei General Hospital

    Asahikawa, Hokkaido, 078-8211

  • Honatsugi Medical Clinic

    Atsugi, Kanagawa, 243-0013

  • Medical corporation association Shunshin-kai Inage hospital

    Chiba, 263-0043

  • Chigasaki Central Clinic

    Chigasaki, Kanagawa, 253-0052

  • Koizumi Cardiology Medical Clinic

    Chitose, Hokkaido, 066-0062

  • Ikeda Vascular Access Nephrology Dialysis

    Fukuoka, 810-0012

  • Oohashi internal medicine circulatory Clinic

    Fukuoka, 815-0038

  • Hachioji Azumacho Clinic

    Hachiōji, Tokyo, 192-0082

  • Public Central Hospital of Matto Ishikawa

    Hakusan, Ishikawa-ken, 924-8588

  • Hanyu General Hospital

    Hanyū, Saitama, 348-0045

  • Higashimatsuyamakohjin Clinic

    Higashi-Matsuyama, Saitama, 355-0016

  • Arisawa General Hospital

    Hirakata, Osaka, 573-1195

  • Iida Hospital

    Iida, Nagano, 395-8505

  • Ishikari Hospital

    Ishikari, Hokkaido, 061-3213

  • Ibaraki Prefectural Central Hospital

    Kasama, Ibaraki, 309-1793

  • Shinkashiwa Clinic

    Kashiwa, Chiba, 277-0084

  • Houshikai Kano hospital

    Kasuya-gun, Fukuoka, 811-0120

  • Kisarazu Clinic

    Kisarazu, Chiba, 292-0805

  • Saiseikai Yahata General Hospital

    Kitakyushu, Fukuoka, 805-0050

  • Kodaira Kitaguchi Clinic

    Kodaira, Tokyo, 187-0001

  • Japanese Red Cross Koga Hospital

    Koga, Ibaraki, 306-0014

  • Saiyu Clinic

    Koshigaya, Saitama, 343-0823

  • Ueki Imafuji Clinic

    Kumamoto, 861-0135

  • Seisuikai Yoshioka Mahoroba Clinic

    Kurokawa-gun, Miyagi, 981-3632

  • Kanno Dialysis & Vascular Access Clinic

    Matsumoto, Nagano, 390-0821

  • Matsumoto City Hospital

    Matsumoto, Nagano, 390-1401

  • Sanshikai Toho Hospital

    Midori, Gunma, 379-2311

  • Mito Kyodo General Hospital

    Mito, Ibaraki, 310-0015

  • Medical Corporation Suzukihinyoukika

    Nagano, 380-0904

  • Nagasaki Kidney Hospital

    Nagasaki, 850-0032

  • Hakuyoukai Medical corporation Hakuyoukai Hospital

    Nagoya, Aichi-ken, 465-0025

  • Kuwajima Clinic

    Niihama, Ehime, 792-0812

  • Itami Kidney Clinic

    Noboribetsu, Hokkaido, 059-0026

  • Akagaki Clinic

    Osaka, 543-0052

  • Nishi Shinryosho

    Osaka, 552-0007

  • Chibune Clinic

    Osaka, 555-0001

  • Eijinkai Hospital

    Ōsaki, Miyagi, 989-6117

  • Sabae kidney Clinic

    Sabae, Fukui, 916-0044

  • Toshiba Rinkan Hospital

    Sagamihara, Kanagawa, 252-0385

  • Iwatsuki-minami Hospital

    Saitama, 339-0033

  • Kaisei Hospital

    Sakaidechō, Kagawa-ken, 762-0007

  • Souen Central Hospital

    Sapporo, Hokkaido, 060-0008

  • Todachuo General Hospital

    Toda, Saitama, 335-0023

  • 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

  • Saint Hill Hospital

    Ube, Yamaguchi, 755-0155

  • Maruko Central Hospital

    Ueda, Nagano, 386-0405

  • Yamagata Tokushukai Hospital

    Yamagata, 990-0834

  • Yokohama Jin Clinic

    Yokohama, Kanagawa, 224-0032

  • Eda Clinic

    Yokohama, Kanagawa, 225-0015

  • Kaminagaya Saitou Clinic

    Yokohama, Kanagawa, 233-0013

Other trials in Japan

About this study

Official title: A Randomized, Active-controlled, Double-blinded, Double-dummy, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Dialysis Subjects Treated With Erythropoiesis-Stimulating Agents (ESAs)

The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).

Being tested
Molidustat (BAY85-3934), Darbepoetin alfa, Placebo of Molidustat (BAY85-3934), Placebo of 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 will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).

  • Darbepoetin alfaDrug

    Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.

  • Placebo of Molidustat (BAY85-3934)Drug

    Matching placebo of Molidustat.

  • Placebo of Darbepoetin alfaDrug

    Matching placebo of Darbepoetin alfa.

Study groups in NCT03543657
Study groupRoleWhat they receive
Molidustat groupExperimentalSubjects in the molidustat group will receive molidustat and darbepoetin alfa placebo.
Receives: Drug: Molidustat (BAY85-3934); Drug: Placebo of Darbepoetin alfa
Darbepoetin alfa groupActive comparatorSubjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.
Receives: Drug: Darbepoetin alfa; Drug: Placebo of Molidustat (BAY85-3934)

What is being measured

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

  1. The mean Hb level during the evaluation period

    Measured: From week 33 to 36

  2. The change in mean Hb level during the evaluation period from baseline

    Measured: Baseline and week 33 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 33 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 33 to 36

  3. Hb level

    Measured: Up to 52 weeks

  4. Change in Hb level

    Measured: Baseline and up to 52 weeks

  5. Proportion of subjects whose mean hemoglobin level is in the target range

    Measured: From week 33 to 36

  6. Proportion of subjects whose mean hemoglobin level is above the target range

    Measured: From week 33 to 36

  7. Proportion of subjects whose mean hemoglobin level is below the target range

    Measured: From week 33 to 36

  8. Proportion of subjects with hemoglobin levels in the target range

    Measured: Up to 52 weeks

  9. Proportion of subjects with hemoglobin levels above the target range

    Measured: Up to 52 weeks

  10. Proportion of subjects with hemoglobin levels 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)

    Measured: At baseline, week 8, week 24 and week 52

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

    Measured: At baseline, week 8, week 24 and week 52

  15. EPO (Erythropoietin) serum concentration

    Measured: At baseline, week 8, 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 posted1 Jun 2018
  2. Study start23 Jun 2018
  3. Primary completion7 Aug 2019
  4. Study completion24 Dec 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03543657
Sponsor's protocol ID
19352
Acronym
MIYABI HD-M
Status last verified
Jan 2021
First submitted
22 May 2018
Last updated
29 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

  • Akizawa 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

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 53 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 53 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?

The mean Hb level during the evaluation period (time frame: From week 33 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 NCT03543657, 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.

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