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

Primary Purpose

Anemia, Renal Insufficiency, Chronic

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Molidustat (BAY85-3934)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Houshikai Kano hospital
  • Matsunami General Hospital
  • Asahikawa-Kosei General Hospital
  • Ishikari Hospital
  • Itami Kidney Clinic
  • Souen Central Hospital
  • Takasago Seibu Hospital
  • Japanese Red Cross Koga Hospital
  • Mito Kyodo General Hospital
  • Tokiwa Clinic
  • Tsuchiura Beryl Clinic
  • Kikuchi Medical Clinic
  • Japanese Red Cross Ishinomaki Hospital
  • Iida Hospital
  • Toyonaka Keijinkai Clinic
  • Kodaira Kitaguchi Clinic
  • Medical corporation association Shunshin-kai Inage hospital
  • Fukuoka Renal Clinic
  • Ohmiya Chuo General Hospital
  • Yamagata Tokushukai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Molidustat (BAY85-3934)

Arm Description

Molidustat group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of rise in Hb (Hemoglobin) level (g/dL/week)
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
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit
Hb level
Change in Hb level
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
Proportion of subjects with hemoglobin levels above the target range
Proportion of subjects with hemoglobin levels below the target range
Proportion of subjects with hemoglobin levels in the target range
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)
Number of participants with serious adverse events
Maximum concentration (Cmax) of Molidustat
Area under the concentration-time curve (AUC) of Molidustat
EPO (Erythropoietin) serum concentration of Molidustat

Full Information

First Posted
November 20, 2017
Last Updated
January 28, 2021
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03351166
Brief Title
A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects
Acronym
MIYABI HD-C
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
October 23, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Renal Insufficiency, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Molidustat (BAY85-3934)
Arm Type
Experimental
Arm Description
Molidustat group
Intervention Type
Drug
Intervention Name(s)
Molidustat (BAY85-3934)
Intervention Description
Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
Primary Outcome Measure Information:
Title
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time Frame
Up to 8 weeks
Title
Responder rate: proportion of responders among the subjects
Description
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 21 to 24
Secondary Outcome Measure Information:
Title
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time Frame
Up to 4 weeks
Title
Proportion of subjects who meet each component of the response
Description
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 21 to 24
Title
Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit
Time Frame
Up to 24 weeks
Title
Hb level
Time Frame
Baseline and up to 24 weeks
Title
Change in Hb level
Time Frame
Baseline and up to 24 weeks
Title
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period
Time Frame
Week 21 to 24
Title
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period
Time Frame
Week 21 to 24
Title
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
Time Frame
Week 21 to 24
Title
Proportion of subjects with hemoglobin levels above the target range
Time Frame
Up to 24 weeks
Title
Proportion of subjects with hemoglobin levels below the target range
Time Frame
Up to 24 weeks
Title
Proportion of subjects with hemoglobin levels in the target range
Time Frame
Up to 24 weeks
Title
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week
Description
Defined as change in Hb level / duration between two visits (weeks)
Time Frame
Up to 24 weeks
Title
Number of participants with serious adverse events
Time Frame
Up to 24 weeks
Title
Maximum concentration (Cmax) of Molidustat
Time Frame
Baseline, Week 8, Week16 and Week 24
Title
Area under the concentration-time curve (AUC) of Molidustat
Time Frame
Baseline, Week 8, Week16 and Week 24
Title
EPO (Erythropoietin) serum concentration of Molidustat
Time Frame
Baseline, Week 8, Week16 and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Houshikai Kano hospital
City
Kasuya-gun
State/Province
Fukuoka
ZIP/Postal Code
811-0120
Country
Japan
Facility Name
Matsunami General Hospital
City
Hashima-gun
State/Province
Gifu
ZIP/Postal Code
501-6062
Country
Japan
Facility Name
Asahikawa-Kosei General Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8211
Country
Japan
Facility Name
Ishikari Hospital
City
Ishikari
State/Province
Hokkaido
ZIP/Postal Code
061-3213
Country
Japan
Facility Name
Itami Kidney Clinic
City
Noboribetsu
State/Province
Hokkaido
ZIP/Postal Code
059-0026
Country
Japan
Facility Name
Souen Central Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0008
Country
Japan
Facility Name
Takasago Seibu Hospital
City
Takasago
State/Province
Hyogo
ZIP/Postal Code
676-0812
Country
Japan
Facility Name
Japanese Red Cross Koga Hospital
City
Koga
State/Province
Ibaraki
ZIP/Postal Code
306-0014
Country
Japan
Facility Name
Mito Kyodo General Hospital
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0015
Country
Japan
Facility Name
Tokiwa Clinic
City
Totte
State/Province
Ibaraki
ZIP/Postal Code
302-0011
Country
Japan
Facility Name
Tsuchiura Beryl Clinic
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0062
Country
Japan
Facility Name
Kikuchi Medical Clinic
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-0861
Country
Japan
Facility Name
Japanese Red Cross Ishinomaki Hospital
City
Ishinomaki
State/Province
Miyagi
ZIP/Postal Code
986-8522
Country
Japan
Facility Name
Iida Hospital
City
Iida
State/Province
Nagano
ZIP/Postal Code
395-8505
Country
Japan
Facility Name
Toyonaka Keijinkai Clinic
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-0004
Country
Japan
Facility Name
Kodaira Kitaguchi Clinic
City
Kodaira
State/Province
Tokyo
ZIP/Postal Code
187-0001
Country
Japan
Facility Name
Medical corporation association Shunshin-kai Inage hospital
City
Chiba
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
Fukuoka Renal Clinic
City
Fukuoka
ZIP/Postal Code
810-0004
Country
Japan
Facility Name
Ohmiya Chuo General Hospital
City
Saitama
ZIP/Postal Code
331-8711
Country
Japan
Facility Name
Yamagata Tokushukai Hospital
City
Yamagata
ZIP/Postal Code
990-0834
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33506635
Citation
Akizawa T, Nobori K, Matsuda Y, Hayashi Y, Hayasaki T, Yamamoto H. Molidustat for anemia correction in Japanese patients undergoing hemodialysis: a single-arm, phase 3 study. Ther Apher Dial. 2021 Dec;25(6):917-925. doi: 10.1111/1744-9987.13627. Epub 2021 Mar 22.
Results Reference
derived
PubMed Identifier
31203241
Citation
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.
Results Reference
derived
Links:
URL
http://clinicaltrials.bayer.com/
Description
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A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects

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