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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
Starting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) response
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
Responder rate: proportion of responders among the subjects
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
Time frame: From week 30 to 36
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
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
Time frame: From week 30 to 36
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
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Kainan Hospital
Yatomi, Aichi-ken, Japan
Seikeikai New Tokyo Heart Clinic
Matsudo, Chiba, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, Japan
Saiseikai Matsuyama Hospital
Matsuyama, Ehime, Japan
Iizuka Hospital
Iizuka, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, Japan
National Fukuoka-Higashi Medical Center
Koga, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
St.Mary's Hospital
Kurume, Fukuoka, Japan
...and 51 more locations
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
Defined as change in Hb level / duration between two visits (weeks)
Time frame: Up to 52 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