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Maintenance Treatment of Renal Anemia in Dialysis Subjects (MIYABI HD-M)

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ClinicalTrials.gov Identifier: NCT03543657
Recruitment Status : Active, not recruiting
First Posted : June 1, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Active-controlled, Double-blinded, Double-dummy, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Dialysis Subjects Treated With Erythropoiesis-Stimulating Agents (ESAs)
Actual Study Start Date : June 23, 2018
Actual Primary Completion Date : August 7, 2019
Estimated Study Completion Date : December 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis

Arm Intervention/treatment
Experimental: Molidustat group
Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo.
Drug: Molidustat (BAY85-3934)
Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).

Drug: Placebo of Darbepoetin alfa
Matching placebo of Darbepoetin alfa.

Active Comparator: Darbepoetin alfa group
Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.
Drug: Darbepoetin alfa
Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.

Drug: Placebo of Molidustat (BAY85-3934)
Matching placebo of Molidustat.




Primary Outcome Measures :
  1. The mean Hb level during the evaluation period [ Time Frame: From week 33 to 36 ]
  2. The change in mean Hb level during the evaluation period from baseline [ Time Frame: Baseline and week 33 to 36 ]

Secondary Outcome Measures :
  1. Responder rate: proportion of responders among the subjects [ Time Frame: From week 33 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 33 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: Up to 52 weeks ]
  4. Change in Hb level [ Time Frame: Baseline and up to 52 weeks ]
  5. Proportion of subjects whose mean hemoglobin level is in the target range [ Time Frame: From week 33 to 36 ]
  6. Proportion of subjects whose mean hemoglobin level is above the target range [ Time Frame: From week 33 to 36 ]
  7. Proportion of subjects whose mean hemoglobin level is below the target range [ Time Frame: From week 33 to 36 ]
  8. Proportion of subjects with hemoglobin levels in the target range [ Time Frame: Up to 52 weeks ]
  9. Proportion of subjects with hemoglobin levels above the target range [ Time Frame: Up to 52 weeks ]
  10. Proportion of subjects with hemoglobin levels 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) [ Time Frame: At baseline, week 8, week 24 and week 52 ]
  14. Area under the concentration-time curve (AUC) [ Time Frame: At baseline, week 8, week 24 and week 52 ]
  15. EPO (Erythropoietin) serum concentration [ Time Frame: At baseline, week 8, week 24 and week 52 ]


Information from the National Library of Medicine

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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 ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization
  • Body weight (after dialysis) > 40 and ≤ 160 kg at screening
  • Male or female subject ≥ 20 years of age at screening
  • At least one kidney
  • Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization
  • Mean screening Hb level ≥ 9.5 and < 12.0 g/dL (mean of all central laboratory Hb levels before dialysis [at least 2 measurements must be taken ≥ 2 days apart] during the 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% at screening
  • Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) 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, 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 agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening

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): NCT03543657


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Sponsors and Collaborators
Bayer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03543657     History of Changes
Other Study ID Numbers: 19352
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Darbepoetin alfa
Hematinics