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

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ClinicalTrials.gov Identifier: NCT03351166
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Anemia and Renal Insufficiency, Chronic Drug: Molidustat (BAY85-3934) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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 : January 22, 2018
Estimated Primary Completion Date : October 13, 2019
Estimated Study Completion Date : November 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

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




Primary Outcome Measures :
  1. Rate of rise in Hb (Hemoglobin) level (g/dL/week) [ Time Frame: Up to 8 weeks ]
  2. 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



Secondary Outcome Measures :
  1. Rate of rise in Hb (Hemoglobin) level (g/dL/week) [ Time Frame: Up to 4 weeks ]
  2. 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


  3. 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 ]
  4. Hb level [ Time Frame: Baseline and up to 24 weeks ]
  5. Change in Hb level [ Time Frame: Baseline and up to 24 weeks ]
  6. Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period [ Time Frame: Week 21 to 24 ]
  7. Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period [ Time Frame: Week 21 to 24 ]
  8. Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period [ Time Frame: Week 21 to 24 ]
  9. Proportion of subjects with hemoglobin levels above the target range [ Time Frame: Up to 24 weeks ]
  10. Proportion of subjects with hemoglobin levels below the target range [ Time Frame: Up to 24 weeks ]
  11. Proportion of subjects with hemoglobin levels in the target range [ Time Frame: Up to 24 weeks ]
  12. 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)

  13. Number of participants with serious adverse events [ Time Frame: Up to 24 weeks ]
  14. Maximum concentration (Cmax) of Molidustat [ Time Frame: Baseline, Week 8, Week16 and Week 24 ]
  15. Area under the concentration-time curve (AUC) of Molidustat [ Time Frame: Baseline, Week 8, Week16 and Week 24 ]
  16. EPO (Erythropoietin) serum concentration of Molidustat [ Time Frame: Baseline, Week 8, Week16 and Week 24 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351166


Contacts
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
Japan
Houshikai Kano hospital Recruiting
Kasuya-gun, Fukuoka, Japan, 811-0120
Matsunami General Hospital Recruiting
Hashima-gun, Gifu, Japan, 501-6062
Asahikawa-Kosei General Hospital Recruiting
Asahikawa, Hokkaido, Japan, 078-8211
Ishikari Hospital Recruiting
Ishikari, Hokkaido, Japan, 061-3213
Itami Kidney Clinic Recruiting
Noboribetsu, Hokkaido, Japan, 059-0026
Souen Central Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-0008
Takasago Seibu Hospital Recruiting
Takasago, Hyogo, Japan, 676-0812
Japanese Red Cross Koga Hospital Recruiting
Koga, Ibaraki, Japan, 306-0014
Mito Kyodo General Hospital Recruiting
Mito, Ibaraki, Japan, 310-0015
Tokiwa Clinic Recruiting
Totte, Ibaraki, Japan, 302-0011
Tsuchiura Beryl Clinic Recruiting
Tsuchiura, Ibaraki, Japan, 300-0062
Kikuchi Medical Clinic Recruiting
Tsukuba, Ibaraki, Japan, 305-0861
Japanese Red Cross Ishinomaki Hospital Recruiting
Ishinomaki, Miyagi, Japan, 986-8522
Seisuikai Yoshioka Mahoroba Clinic Not yet recruiting
Kurokawa-gun, Miyagi, Japan, 981-3632
Iida Hospital Recruiting
Iida, Nagano, Japan, 395-8505
Toyonaka Keijinkai Clinic Recruiting
Toyonaka, Osaka, Japan, 560-0004
Kodaira Kitaguchi Clinic Recruiting
Kodaira, Tokyo, Japan, 187-0001
Inage Hospital Recruiting
Chiba, Japan, 263-0043
Fukuoka Renal Clinic Recruiting
Fukuoka, Japan, 810-0004
Ohmiya Chuo General Hospital Recruiting
Saitama, Japan, 331-8711
Yamagata Tokushukai Hospital Recruiting
Yamagata, Japan, 990-0834
Sponsors and Collaborators
Bayer

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03351166     History of Changes
Other Study ID Numbers: 19351
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Hematinics