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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Starting dose of 25 mg or 50 mg molidustat once daily (OD) will be titrated based on the subject's Hb response
Starting dose and frequency of darbepoetin alfa are based on previous ESA. The dose will be titrated based on the subject's Hb 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
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
Hb level
Time frame: Baseline and up to 52 weeks
Change in Hb level
Time frame: Baseline and up to 52 weeks
Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period
Time frame: From week 30 to 36
Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period
Time frame: From week 30 to 36
Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period
Time frame: From week 30 to 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 49 more locations
Proportion of subjects whose hemoglobin levels are in the target range
Time frame: Up to 52 weeks
Proportion of subjects whose hemoglobin levels are above the target range
Time frame: Up to 52 weeks
Proportion of subjects whose hemoglobin levels are 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) of Molidustat
Time frame: At baseline, week 12, week 24 and week 52
Area under the concentration-time curve (AUC) of Molidustat
Time frame: At baseline, week 12, week 24 and week 52
EPO (Erythropoietin) serum concentration of Molidustat
Time frame: At baseline, week 12, week 24 and week 52