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A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects (MIYABI ND-C)

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ClinicalTrials.gov Identifier: NCT03350321
Recruitment Status : Active, not recruiting
First Posted : November 22, 2017
Last Update Posted : November 20, 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 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) Drug: Darbepoetin alfa Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 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 With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : May 24, 2019
Estimated Study Completion Date : October 11, 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

Active Comparator: Darbepoetin alfa
Darbepoetin alfa group
Drug: Darbepoetin alfa
Starting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) 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. Rate of rise in Hb (Hemoglobin) level (g/dL/week) [ Time Frame: Up to 8 weeks ]
  3. Rate of rise in Hb (Hemoglobin) level (g/dL/week) [ Time Frame: Up to 4 weeks ]
  4. 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


  5. Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once [ Time Frame: Up to 52 weeks ]
  6. Change in Hb level [ Time Frame: Baseline and up to 52 weeks ]
  7. Hb level [ Time Frame: Baseline and up to 52 weeks ]
  8. Proportion of subjects whose mean hemoglobin level is in the target range [ Time Frame: From week 30 to 36 ]
  9. Proportion of subjects whose mean hemoglobin level is above the target range [ Time Frame: From week 30 to 36 ]
  10. Proportion of subjects whose mean hemoglobin level is below the target range [ Time Frame: From week 30 to 36 ]
  11. Proportion of subjects with hemoglobin levels in the target range [ Time Frame: Up to 52 weeks ]
  12. Proportion of subjects with hemoglobin levels above the target range [ Time Frame: Up to 52 weeks ]
  13. Proportion of subjects with hemoglobin levels below the target range [ Time Frame: Up to 52 weeks ]
  14. 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)

  15. Number of participants with serious adverse events [ Time Frame: Up to 52 weeks ]
  16. Maximum concentration (Cmax) [ Time Frame: At baseline, week 12, week 24 and week 52 ]
  17. Area under the concentration-time curve (AUC) [ Time Frame: At baseline, week 12, week 24 and week 52 ]
  18. EPO (Erythropoietin) serum concentration [ 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)
  • 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
  • Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization
  • Mean of the last 2 central laboratory Hb levels during the screening period must be ≥ 8.0 and < 11.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) and the last measurements must be taken within 14 days prior to randomization
  • 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): NCT03350321


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Sponsors and Collaborators
Bayer

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03350321     History of Changes
Other Study ID Numbers: 19349
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 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
Darbepoetin alfa
Hematinics