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MIYABI ND-C: A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03350321
Collaborator
(none)
162
Enrollment
61
Locations
2
Arms
21.9
Actual Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Molidustat (BAY85-3934)
  • Drug: Darbepoetin alfa
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Dec 12, 2017
Actual Primary Completion Date :
May 17, 2019
Actual Study Completion Date :
Oct 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Molidustat (BAY85-3934)

Molidustat group

Drug: Molidustat (BAY85-3934)
Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
Active Comparator: Darbepoetin alfa

Darbepoetin alfa group

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

Outcome Measures

Primary Outcome Measures

  1. Mean Hb (Hemoglobin) level [From week 30 to 36]

  2. Change in hemoglobin level from baseline to the average during the evaluation period [Baseline and week 30 to 36]

Secondary Outcome Measures

  1. Responder rate: proportion of responders among the subjects [From week 30 to 36]

    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

  2. Rate of rise in Hb (Hemoglobin) level (g/dL/week) [Up to 8 weeks]

  3. Rate of rise in Hb (Hemoglobin) level (g/dL/week) [Up to 4 weeks]

  4. Proportion of subjects who meet each component of the response [From week 30 to 36]

    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

  5. Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once [Up to 52 weeks]

  6. Change in Hb level [Baseline and up to 52 weeks]

  7. Hb level [Baseline and up to 52 weeks]

  8. Proportion of subjects whose mean hemoglobin level is in the target range [From week 30 to 36]

  9. Proportion of subjects whose mean hemoglobin level is above the target range [From week 30 to 36]

  10. Proportion of subjects whose mean hemoglobin level is below the target range [From week 30 to 36]

  11. Proportion of subjects with hemoglobin levels in the target range [Up to 52 weeks]

  12. Proportion of subjects with hemoglobin levels above the target range [Up to 52 weeks]

  13. Proportion of subjects with hemoglobin levels below the target range [Up to 52 weeks]

  14. Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week [Up to 52 weeks]

    Defined as change in Hb level / duration between two visits (weeks)

  15. Number of participants with serious adverse events [Up to 52 weeks]

  16. Maximum concentration (Cmax) [At baseline, week 12, week 24 and week 52]

  17. Area under the concentration-time curve (AUC) [At baseline, week 12, week 24 and week 52]

  18. EPO (Erythropoietin) serum concentration [At baseline, week 12, week 24 and week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kainan Hospital Yatomi Aichi Japan 498-8502
2 Seikeikai New Tokyo Heart Clinic Matsudo Chiba Japan 271-0077
3 Ehime Prefectural Central Hospital Matsuyama Ehime Japan 790-0024
4 Saiseikai Matsuyama Hospital Matsuyama Ehime Japan 791-8026
5 Iizuka Hospital Iizuka Fukuoka Japan 820-8505
6 Kokura Memorial Hospital Kitakyushu Fukuoka Japan 802-8555
7 Steel Memorial Yawata Hospital Kitakyushu Fukuoka Japan 805-8508
8 National Fukuoka-Higashi Medical Center Koga Fukuoka Japan 811-3195
9 Kurume University Hospital Kurume Fukuoka Japan 830-0011
10 St.Mary's Hospital Kurume Fukuoka Japan 830-8543
11 Matsunami Health Promotion Clinic Hashima-gun Gifu Japan 501-6061
12 Gifu Prefectural Tajimi Hospital Tajimi Gifu Japan 507-8522
13 Mazda Hospital of Mazda Motor Corporation Aki-gun Hiroshima Japan 735-8585
14 Nippon Kokan Fukuyama Hospital Fukuyama Hiroshima Japan 721-0927
15 Teine Keijinkai Clinic Sapporo Hokkaido Japan 006-8555
16 Kobe City Medical Center General Hospital Kobe Hyogo Japan 650-0047
17 National Hospital Organization Kobe Medical Center Kobe Hyogo Japan 654-0155
18 National hospital Organization Mito Medical Center Higashiibaraki Ibaraki Japan 311-3193
19 Mito Kyodo General Hospital Mito Ibaraki Japan 310-0015
20 KenAiKai medical corporation Akiyama clinic Takamatsu Kagawa Japan 761-1701
21 Ikeda Hospital Kanoya Kagoshima Japan 893-0024
22 Fujisawa City Hospital Fujisawa Kanagawa Japan 251-8550
23 Koukan Clinic Kawasaki Kanagawa Japan 210-0852
24 Showa University Fujigaoka Hospital Yokohama Kanagawa Japan 227-8501
25 Yokosuka Kyosai Hospital Yokosuka Kanagawa Japan 238-8558
26 Arao Municipal Hospital Arao Kumamoto Japan 864-0041
27 Kumamoto Rosai Hospital Yatsushiro Kumamoto Japan 866-8533
28 Uji-Tokushukai Medical Center Uji Kyoto Japan 611-0041
29 JCHO Yokkaichi Hazu Medical Center Yokkaichi Mie Japan 510-0016
30 Japanese Red Cross Ishinomaki Hospital Ishinomaki Miyagi Japan 986-8522
31 Asama Nanroku Komoro Medical Center Komoro Nagano Japan 384-8588
32 Niigata Prefectural Shibata Hospital Shibata Niigata Japan 957-8588
33 Okinawa prefectural Chubu Hospital Uruma Okinawa Japan 904-2293
34 Osaka Saiseikai Senri Hospital Suita Osaka Japan 565-0862
35 Osaka Pref. Saiseikai Tondabayashi Hospital Tondabayashi Osaka Japan 584-0082
36 Kitasato University Medical Center Kitamoto Saitama Japan 364-8501
37 Iwata City Hospital Iwata Shizuoka Japan 438-8550
38 Toshima Hospital Itabashi-ku Tokyo Japan 173-0015
39 Nihon University Itabashi Hospital Itabashi-ku Tokyo Japan 173-8610
40 Showa University Koto Toyosu Hospital Koto-ku Tokyo Japan 135-8577
41 National Hospital Organization Tokyo Medical Center Meguro-ku Tokyo Japan 152-8902
42 University of Yamanashi Hospital Chuo Yamanashi Japan 409-3898
43 Fukui Prefectural Hospital Fukui Japan 910-8526
44 National Hospital Organization Kyushu Medical Center Fukuoka Japan 810-8563
45 Kyushu University Hospital Fukuoka Japan 812-8582
46 Fukuoka University Hospital Fukuoka Japan 814-0180
47 Fukushima Medical University Hospital Fukushima Japan 960-1295
48 Asahi University Hospital Gifu Japan 500-8523
49 National Hospital Organization Kochi National Hospital Kochi Japan 780-8077
50 Nara Prefecture General Medical Center Nara Japan 630-8581
51 Japanese Red Cross Oita Hospital Oita Japan 870-0033
52 Kitano Hospital Osaka Japan 530-8480
53 National Hospital Organization Osaka National Hospital Osaka Japan 540-0006
54 Osaka Red Cross Hospital Osaka Japan 543-8555
55 Nippon Life Hospital Osaka Japan 550-0006
56 Chibune Clinic Osaka Japan 555-0001
57 Osaka General Medical Center Osaka Japan 558-8558
58 Social Corporation Keigakukai Minamiosaka Hospital Osaka Japan 559-0012
59 Shizuoka Saiseikai General Hospital Shizuoka Japan 422-8527
60 Suruga Clinic Shizuoka Japan 424-0855
61 Wakayama Medical University Hospital Wakayama Japan 641-8510

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03350321
Other Study ID Numbers:
  • 19349
First Posted:
Nov 22, 2017
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Anemia
Darbepoetin alfa

Study Results

No Results Posted as of Jan 29, 2021