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AnemiaPhase 3MIYABI PDNCT03418168

A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects

A Phase 3 study testing Molidustat (BAY85-3934) in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 27 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 peritoneal dialysis subjects with renal anemia 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
51 participants
Where
27 sitesJapan
Study dates
22 Feb 2018to 29 Jul 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 end-stage kidney disease (ESKD) on peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period
  • Body weight > 40 and ≤ 160 kg at screening
  • Male or female subject ≥ 20 years of age at screening
  • At least one kidney
  • Subjects who meet one of the 1 or 2 following criteria
  • Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) 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) with the last screening Hb measurement within 14 days prior to study drug assignment
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  • Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 10.0 and < 13.0 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
  • Subjects who meet one of the 1 or 2 following criteria
  • Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken ≥ 2 days apart) has decrease to ≥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol
  • Subjects pre treated with ESA at assignment:
  • Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment
  • Subject treated with ESA by IV or SC within 8 weeks prior to assignment
  • Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment

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

27 sites in 1 country.

27 sites in 1 country

Japan27 sites

  • National Hospital Organization Beppu Medical Center

    Beppu, Oita Prefecture, 874-0011

  • Fujisawa City Hospital

    Fujisawa, Kanagawa, 251-8550

  • Fukui-ken Saiseikai Hospital

    Fukui, 918-8503

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, 815-8555

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Asahi University Hospital

    Gifu, 500-8523

  • Fuchu Hospital

    Izumi, Osaka, 594-0076

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa, 247-8533

  • Toranomon Hospital Kajigaya

    Kawasaki, Kanagawa, 213-8587

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • JCHO Kyushu Hospital

    Kitakyushu, Fukuoka, 806-8501

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime, 790-0024

  • Nara Prefecture General Medical Center

    Nara, 630-8581

  • Niigata City General Hospital

    Niigata, 950-1197

  • Japanese Red Cross Oita Hospital

    Ōita, 870-0033

  • Osaka General Medical Center

    Osaka, 558-8558

  • Elm Grove Clinic

    Sapporo, Hokkaido, 003-0814

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, Miyagi, 983-8512

  • Niigata Prefectural Shibata Hospital

    Shibata, Niigata, 957-8588

  • Okinawa prefectural Chubu Hospital

    Uruma, Okinawa, 904-2293

  • Kainan Hospital

    Yatomi, Aichi-ken, 498-8502

  • Showa University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8501

Other trials in Japan

About this study

Official title: An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia

The purpose of this study is to evaluate the efficacy and safety of molidustat in peritoneal dialysis subjects with renal anemia

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 groups in NCT03418168
Study groupRoleWhat they receive
Molidustat (BAY85-3934)ExperimentalMolidustat group
Receives: Drug: Molidustat (BAY85-3934)

What is being measured

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

  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: Week 30 to 36

Secondary outcomes (25)

  1. Mean Hb (Hemoglobin) level

    Measured: Week 30 to 36

  2. Change in mean Hb level

    Measured: Baseline and Week 30 to 36

  3. Rate of rise in Hb (Hemoglobin) level (g/dL/week)

    Measured: Up to 8 weeks

  4. Rate of rise in Hb (Hemoglobin) level (g/dL/week)

    Measured: Up to 4 weeks

  5. 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 30 to 36

  6. Hb level

    Measured: Baseline and Up to Week 36

  7. Change in Hb level

    Measured: Baseline and Up to Week 36

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

    Measured: Week 30 to 36

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

    Measured: Week 30 to 36

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

    Measured: Week 30 to 36

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

    Measured: Up to 36 weeks

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

    Measured: Up to 36 weeks

  13. Proportion of subjects with hemoglobin levels below the target range

    Measured: Up to 36 weeks

  14. 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 36 weeks

  15. Percentage of days in the target Hb range during the evaluation period

    Measured: Week 30 to 36

  16. Percentage of days in the target Hb range during the treatment period

    Measured: Up to 36 weeks

  17. Rate of rise in Hb level (g/dL/week) between each consecutive visits

    Measured: Up to 36 weeks

  18. Percentage of Hb levels in target range during the evaluation period

    Defined as the number of measurements in the target range / number of measurements x 100 [%])

    Measured: Week 30 to 36

  19. Percentage of Hb levels in target range during the treatment period

    Defined as the number of measurements in the target range / number of measurements x 100 [%])

    Measured: Up to 36 weeks

  20. Proportion of subjects who received at least one rescue treatment

    Measured: Up to 36 weeks

  21. Proportion of subjects whose Hb level was ≥ 13.0 g/dL or < 8.0 g/dL

    Measured: Up to 36 weeks

  22. Number of participants with serious adverse events

    Measured: Up to 36 weeks

  23. Maximum concentration (Cmax) of Molidustat

    Measured: Baseline, Week 8, Wee16 and Week 36

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

    Measured: Baseline, Week 8, Wee16 and Week 36

  25. EPO (Erythropoietin) serum concentration of Molidustat

    Measured: Baseline, Week 8, Wee16 and Week 36

Timeline

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

  1. First posted1 Feb 2018
  2. Study start22 Feb 2018
  3. Primary completion25 Jul 2019
  4. Study completion29 Jul 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03418168
Sponsor's protocol ID
19353
Acronym
MIYABI PD
Status last verified
Jan 2021
First submitted
26 Jan 2018
Last updated
29 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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) in people with Anemia and Renal Insufficiency, Chronic, run by Bayer at 27 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 13 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 27 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?

Responder rate: proportion of responders among the subjects (time frame: Week 30 to 36). 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 NCT03418168, which also lists 1 linked publication.

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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