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MIYABI HD-C: A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03351166
Collaborator
(none)
25
Enrollment
20
Locations
1
Arm
9.9
Actual Duration (Months)
1.3
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 dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)

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

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)
Actual Study Start Date :
Jan 22, 2018
Actual Primary Completion Date :
Oct 23, 2018
Actual Study Completion Date :
Nov 20, 2018

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

Outcome Measures

Primary Outcome Measures

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

  2. Responder rate: proportion of responders among the subjects [Week 21 to 24]

    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

Secondary Outcome Measures

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

  2. Proportion of subjects who meet each component of the response [Week 21 to 24]

    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

  3. Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit [Up to 24 weeks]

  4. Hb level [Baseline and up to 24 weeks]

  5. Change in Hb level [Baseline and up to 24 weeks]

  6. Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period [Week 21 to 24]

  7. Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period [Week 21 to 24]

  8. Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period [Week 21 to 24]

  9. Proportion of subjects with hemoglobin levels above the target range [Up to 24 weeks]

  10. Proportion of subjects with hemoglobin levels below the target range [Up to 24 weeks]

  11. Proportion of subjects with hemoglobin levels in the target range [Up to 24 weeks]

  12. Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week [Up to 24 weeks]

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

  13. Number of participants with serious adverse events [Up to 24 weeks]

  14. Maximum concentration (Cmax) of Molidustat [Baseline, Week 8, Week16 and Week 24]

  15. Area under the concentration-time curve (AUC) of Molidustat [Baseline, Week 8, Week16 and Week 24]

  16. EPO (Erythropoietin) serum concentration of Molidustat [Baseline, Week 8, Week16 and Week 24]

Eligibility Criteria

Criteria

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

  • Subject with end-stage kidney disease (ESKD) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly

  • Body weight > 40 and ≤ 160 kg at screening

  • Male or female subject ≥ 20 years of age at screening

  • At least one kidney

  • Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol

  • Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and < 10.0 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

  • 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 Houshikai Kano hospital Kasuya-gun Fukuoka Japan 811-0120
2 Matsunami General Hospital Hashima-gun Gifu Japan 501-6062
3 Asahikawa-Kosei General Hospital Asahikawa Hokkaido Japan 078-8211
4 Ishikari Hospital Ishikari Hokkaido Japan 061-3213
5 Itami Kidney Clinic Noboribetsu Hokkaido Japan 059-0026
6 Souen Central Hospital Sapporo Hokkaido Japan 060-0008
7 Takasago Seibu Hospital Takasago Hyogo Japan 676-0812
8 Japanese Red Cross Koga Hospital Koga Ibaraki Japan 306-0014
9 Mito Kyodo General Hospital Mito Ibaraki Japan 310-0015
10 Tokiwa Clinic Totte Ibaraki Japan 302-0011
11 Tsuchiura Beryl Clinic Tsuchiura Ibaraki Japan 300-0062
12 Kikuchi Medical Clinic Tsukuba Ibaraki Japan 305-0861
13 Japanese Red Cross Ishinomaki Hospital Ishinomaki Miyagi Japan 986-8522
14 Iida Hospital Iida Nagano Japan 395-8505
15 Toyonaka Keijinkai Clinic Toyonaka Osaka Japan 560-0004
16 Kodaira Kitaguchi Clinic Kodaira Tokyo Japan 187-0001
17 Medical corporation association Shunshin-kai Inage hospital Chiba Japan 263-0043
18 Fukuoka Renal Clinic Fukuoka Japan 810-0004
19 Ohmiya Chuo General Hospital Saitama Japan 331-8711
20 Yamagata Tokushukai Hospital Yamagata Japan 990-0834

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:
NCT03351166
Other Study ID Numbers:
  • 19351
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

Study Results

No Results Posted as of Jan 29, 2021