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A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects (MIYABI ND-M)

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ClinicalTrials.gov Identifier: NCT03350347
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 non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)

Condition or disease Intervention/treatment Phase
Anemia and Renal Insufficiency, Chronic Drug: Molidustat (BAY85-3934) Drug: Darbepoetin alfa Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 Previously Treated With Erythropoiesis-Stimulating Agents (ESAs)
Actual Study Start Date : December 13, 2017
Estimated Primary Completion Date : July 10, 2019
Estimated Study Completion Date : November 29, 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 25 mg or 50 mg molidustat once daily (OD) will be titrated based on the subject's Hb response

Active Comparator: Darbepoetin alfa
Darbepoetin alfa group
Drug: Darbepoetin alfa
Starting dose and frequency of darbepoetin alfa are based on previous ESA. The dose will be titrated based on the subject's Hb response




Primary Outcome Measures :
  1. Mean Hb (Hemoglobin) level [ Time Frame: From week 30 to 36 ]
  2. Change in hemoglobin level from baseline to the average during the evaluation period [ Time Frame: Baseline and week 30 to 36 ]

Secondary Outcome Measures :
  1. Responder rate: proportion of responders among the subjects [ Time Frame: 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. Proportion of subjects who meet each component of the response [ Time Frame: 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


  3. Hb level [ Time Frame: Baseline and up to 52 weeks ]
  4. Change in Hb level [ Time Frame: Baseline and up to 52 weeks ]
  5. Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period [ Time Frame: From week 30 to 36 ]
  6. Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period [ Time Frame: From week 30 to 36 ]
  7. Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period [ Time Frame: From week 30 to 36 ]
  8. Proportion of subjects whose hemoglobin levels are in the target range [ Time Frame: Up to 52 weeks ]
  9. Proportion of subjects whose hemoglobin levels are above the target range [ Time Frame: Up to 52 weeks ]
  10. Proportion of subjects whose hemoglobin levels are below the target range [ Time Frame: Up to 52 weeks ]
  11. Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week [ Time Frame: Up to 52 weeks ]
    Defined as change in Hb level / duration between two visits (weeks)

  12. Number of participants with serious adverse events [ Time Frame: Up to 52 weeks ]
  13. Maximum concentration (Cmax) of Molidustat [ Time Frame: At baseline, week 12, week 24 and week 52 ]
  14. Area under the concentration-time curve (AUC) of Molidustat [ Time Frame: At baseline, week 12, week 24 and week 52 ]
  15. EPO (Erythropoietin) serum concentration of Molidustat [ Time Frame: At baseline, week 12, week 24 and week 52 ]


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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:

  • Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic kidney disease [CKD] stages 3 to 5)
  • Have used the same ESA for 8 weeks prior to screening
  • Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization
  • 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
  • Mean screening Hb level ≥ 10.0 and < 13.0 g/dL (mean of all central laboratory Hb levels [at least 2 measurements must be taken ≥ 2 days apart] during the 8-week screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is < 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization
  • Ferritin ≥ 100 ng/mL or Transferrin saturation ≥ 20%

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 (blood pressure)≥ 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): NCT03350347


Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 59 Study Locations
Sponsors and Collaborators
Bayer

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03350347     History of Changes
Other Study ID Numbers: 19350
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

Keywords provided by Bayer:
Renal anemia

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