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

January 28, 2021 updated by: Bayer

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time Frame: Up to 8 weeks
Up to 8 weeks
Responder rate: proportion of responders among the subjects
Time Frame: 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
Week 21 to 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
Time Frame: Up to 4 weeks
Up to 4 weeks
Proportion of subjects who meet each component of the response
Time Frame: 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
Week 21 to 24
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
Up to 24 weeks
Hb level
Time Frame: Baseline and up to 24 weeks
Baseline and up to 24 weeks
Change in Hb level
Time Frame: Baseline and up to 24 weeks
Baseline and up to 24 weeks
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period
Time Frame: Week 21 to 24
Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period
Time Frame: Week 21 to 24
Week 21 to 24
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
Time Frame: Week 21 to 24
Week 21 to 24
Proportion of subjects with hemoglobin levels above the target range
Time Frame: Up to 24 weeks
Up to 24 weeks
Proportion of subjects with hemoglobin levels below the target range
Time Frame: Up to 24 weeks
Up to 24 weeks
Proportion of subjects with hemoglobin levels in the target range
Time Frame: Up to 24 weeks
Up to 24 weeks
Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week
Time Frame: Up to 24 weeks
Defined as change in Hb level / duration between two visits (weeks)
Up to 24 weeks
Number of participants with serious adverse events
Time Frame: Up to 24 weeks
Up to 24 weeks
Maximum concentration (Cmax) of Molidustat
Time Frame: Baseline, Week 8, Week16 and Week 24
Baseline, Week 8, Week16 and Week 24
Area under the concentration-time curve (AUC) of Molidustat
Time Frame: Baseline, Week 8, Week16 and Week 24
Baseline, Week 8, Week16 and Week 24
EPO (Erythropoietin) serum concentration of Molidustat
Time Frame: Baseline, Week 8, Week16 and Week 24
Baseline, Week 8, Week16 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Actual)

October 23, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19351

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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