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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
229
Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).
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.
Matching placebo of Molidustat.
The mean Hb level during the evaluation period
Time frame: From week 33 to 36
The change in mean Hb level during the evaluation period from baseline
Time frame: Baseline and week 33 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 33 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 33 to 36
Hb level
Time frame: Up to 52 weeks
Change in 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 33 to 36
Proportion of subjects whose mean hemoglobin level is above the target range
Time frame: From week 33 to 36
Proportion of subjects whose mean hemoglobin level is below the target range
Time frame: From week 33 to 36
Proportion of subjects with hemoglobin levels in the target range
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Matching placebo of Darbepoetin alfa.
Hakuyoukai Medical corporation Hakuyoukai Hospital
Nagoya, Aichi-ken, Japan
Shinkashiwa Clinic
Kashiwa, Chiba, Japan
Kisarazu Clinic
Kisarazu, Chiba, Japan
Kuwajima Clinic
Niihama, Ehime, Japan
Sabae kidney Clinic
Sabae, Fukui, Japan
Houshikai Kano hospital
Kasuya-gun, Fukuoka, Japan
Saiseikai Yahata General Hospital
Kitakyushu, Fukuoka, Japan
Sanshikai Toho Hospital
Midori, Gunma, Japan
Asahikawa-Kosei General Hospital
Asahikawa, Hokkaido, Japan
Koizumi Cardiology Medical Clinic
Chitose, Hokkaido, Japan
...and 43 more locations
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 8, week 24 and week 52
Area under the concentration-time curve (AUC)
Time frame: At baseline, week 8, week 24 and week 52
EPO (Erythropoietin) serum concentration
Time frame: At baseline, week 8, week 24 and week 52