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CompletedNCT03418168MIYABI PDUpdated Jan 29, 2021

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

A Phase 3 interventional study of Molidustat (BAY85-3934) in Anemia and Renal Insufficiency, Chronic, sponsored by Bayer. Completed at 27 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

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Phase
Phase 3
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies testing molidustat in Anemia — none open to participants now, none under way, none of them phase 3. molidustat · Anemia.

Enrollment
10th of 13
51 · median 121
Started
2018
with 2 others
Phase 3
5 of 13
none open now
Registered
12th of 13
by date
Lead sponsor
13 of 13
Bayer

Among the 13 studies testing molidustat in Anemia, this one is the 10th largest by enrollment, is one of 3 that started in 2018, is one of 5 in phase 3, and was the 12th registered.

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

Browse Anemia studies →

Open to participants now

None of the 13 studies testing molidustat in Anemia is open now. The open studies under Anemia, anywhere →

About molidustat

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.

This study: 20 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 13 studies testing molidustat in Anemia as a file.
02

Study summary

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

03

Conditions studied

  • Anemia
  • Renal Insufficiency, Chronic
04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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
    • 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

Exclusion criteria

Exclusion Criteria:

  • (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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Molidustat (BAY85-3934)

    Molidustat group

    Drug: Molidustat (BAY85-3934)

Interventions

  • DrugMolidustat (BAY85-3934)

    Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response

06

What researchers measure

Primary outcomes

  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

    Time frame: Week 30 to 36

Secondary outcomes

  1. Mean Hb (Hemoglobin) level

    Time frame: Week 30 to 36

  2. Change in mean Hb level

    Time frame: Baseline and Week 30 to 36

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

    Time frame: Up to 8 weeks

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

    Time frame: 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

    Time frame: Week 30 to 36

  6. Hb level

    Time frame: Baseline and Up to Week 36

  7. Change in Hb level

    Time frame: Baseline and Up to Week 36

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

    Time frame: Week 30 to 36

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

    Time frame: Week 30 to 36

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

    Time frame: Week 30 to 36

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

    Time frame: Up to 36 weeks

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

    Time frame: Up to 36 weeks

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

    Time frame: 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)

    Time frame: Up to 36 weeks

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

    Time frame: Week 30 to 36

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

    Time frame: Up to 36 weeks

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

    Time frame: 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 \[%\])

    Time frame: 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 \[%\])

    Time frame: Up to 36 weeks

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

    Time frame: Up to 36 weeks

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

    Time frame: Up to 36 weeks

  22. Number of participants with serious adverse events

    Time frame: Up to 36 weeks

  23. Maximum concentration (Cmax) of Molidustat

    Time frame: Baseline, Week 8, Wee16 and Week 36

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

    Time frame: Baseline, Week 8, Wee16 and Week 36

  25. EPO (Erythropoietin) serum concentration of Molidustat

    Time frame: Baseline, Week 8, Wee16 and Week 36

07

Study locations

27 sites
  • Kainan Hospital
    Yatomi, Aichi 498-8502, Japan
  • Ehime Prefectural Central Hospital
    Matsuyama, Ehime 790-0024, Japan
  • Kokura Memorial Hospital
    Kitakyushu, Fukuoka 802-8555, Japan
  • JCHO Kyushu Hospital
    Kitakyushu, Fukuoka 806-8501, Japan
  • Kurume University Hospital
    Kurume, Fukuoka 830-0011, Japan
  • Elm Grove Clinic
    Sapporo, Hokkaido 003-0814, Japan
  • Kobe City Medical Center General Hospital
    Kobe, Hyogo 650-0047, Japan
  • Fujisawa City Hospital
    Fujisawa, Kanagawa 251-8550, Japan
  • Shonan Kamakura General Hospital
    Kamakura, Kanagawa 247-8533, Japan
  • Toranomon Hospital Kajigaya
    Kawasaki, Kanagawa 213-8587, Japan
  • Showa University Fujigaoka Hospital
    Yokohama, Kanagawa 227-8501, Japan
  • Tohoku Medical and Pharmaceutical University Hospital
    Sendai, Miyagi 983-8512, Japan
  • Niigata Prefectural Shibata Hospital
    Shibata, Niigata 957-8588, Japan
  • National Hospital Organization Beppu Medical Center
    Beppu, Oita 874-0011, Japan
  • Okinawa prefectural Chubu Hospital
    Uruma, Okinawa 904-2293, Japan
  • Fuchu Hospital
    Izumi, Osaka 594-0076, Japan
  • Fukui-ken Saiseikai Hospital
    Fukui, 918-8503, Japan
  • Kyushu University Hospital
    Fukuoka, 812-8582, Japan
  • Fukuoka University Hospital
    Fukuoka, 814-0180, Japan
  • Japanese Red Cross Fukuoka Hospital
    Fukuoka, 815-8555, Japan
  • Fukushima Medical University Hospital
    Fukushima, 960-1295, Japan
  • Asahi University Hospital
    Gifu, 500-8523, Japan
  • National Hospital Organization Kyoto Medical Center
    Kyoto, 612-8555, Japan
  • Nara Prefecture General Medical Center
    Nara, 630-8581, Japan
  • Niigata City General Hospital
    Niigata, 950-1197, Japan
  • Japanese Red Cross Oita Hospital
    Oita, 870-0033, Japan
  • Osaka General Medical Center
    Osaka, 558-8558, Japan
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Jul 2019, 17 months.

Of 98 industry-sponsored phase 3 interventional studies under Anemia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's 17 months is below that.

Counting every sponsor, half of 150 studies reached it within 30 months; a quarter within 17 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 1, 2018
StartActual
Feb 22, 2018
Primary completionActual
Jul 25, 2019
CompletionActual
Jul 29, 2019
Last update
Jan 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03418168
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
Feb 22, 2018
Primary completion
Jul 25, 2019
Completion
Jul 29, 2019
Last update
Jan 29, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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