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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 : Completed
First Posted : November 22, 2017
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE November 19, 2017
First Posted Date  ICMJE November 22, 2017
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE December 12, 2017
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2017)
  • Mean Hb (Hemoglobin) level [ Time Frame: From week 30 to 36 ]
  • Change in hemoglobin level from baseline to the average during the evaluation period [ Time Frame: Baseline and week 30 to 36 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03350321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2017)
  • 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
  • Rate of rise in Hb (Hemoglobin) level (g/dL/week) [ Time Frame: Up to 8 weeks ]
  • Rate of rise in Hb (Hemoglobin) level (g/dL/week) [ Time Frame: Up to 4 weeks ]
  • 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
  • Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once [ Time Frame: Up to 52 weeks ]
  • Change in Hb level [ Time Frame: Baseline and up to 52 weeks ]
  • Hb level [ Time Frame: Baseline and up to 52 weeks ]
  • Proportion of subjects whose mean hemoglobin level is in the target range [ Time Frame: From week 30 to 36 ]
  • Proportion of subjects whose mean hemoglobin level is above the target range [ Time Frame: From week 30 to 36 ]
  • Proportion of subjects whose mean hemoglobin level is below the target range [ Time Frame: From week 30 to 36 ]
  • Proportion of subjects with hemoglobin levels in the target range [ Time Frame: Up to 52 weeks ]
  • Proportion of subjects with hemoglobin levels above the target range [ Time Frame: Up to 52 weeks ]
  • Proportion of subjects with hemoglobin levels below the target range [ Time Frame: Up to 52 weeks ]
  • 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)
  • Number of participants with serious adverse events [ Time Frame: Up to 52 weeks ]
  • Maximum concentration (Cmax) [ Time Frame: At baseline, week 12, week 24 and week 52 ]
  • Area under the concentration-time curve (AUC) [ Time Frame: At baseline, week 12, week 24 and week 52 ]
  • EPO (Erythropoietin) serum concentration [ Time Frame: At baseline, week 12, week 24 and week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Renal Insufficiency, Chronic
Intervention  ICMJE
  • Drug: Molidustat (BAY85-3934)
    Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
  • Drug: Darbepoetin alfa
    Starting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) response
Study Arms  ICMJE
  • Experimental: Molidustat (BAY85-3934)
    Molidustat group
    Intervention: Drug: Molidustat (BAY85-3934)
  • Active Comparator: Darbepoetin alfa
    Darbepoetin alfa group
    Intervention: Drug: Darbepoetin alfa
Publications * Yamamoto H, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Akizawa T. Molidustat for the treatment of renal anaemia in patients with non-dialysis-dependent chronic kidney disease: design and rationale of two phase III studies. BMJ Open. 2019 Jun 14;9(6):e026704. doi: 10.1136/bmjopen-2018-026704.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2018)
166
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2017)
150
Actual Study Completion Date  ICMJE October 11, 2019
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03350321
Other Study ID Numbers  ICMJE 19349
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bayer
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP