A Phase 2 interventional study of Molidustat (BAY 85-3934) and Epoetin alfa/beta in Anemia and Renal Insufficiency, Chronic, sponsored by Bayer. Completed at 35 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-20.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day
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Starting dose of 25 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits. Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
Drug: Molidustat (BAY 85-3934)
Starting dose of 50 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
Drug: Molidustat (BAY 85-3934)
Starting dose of 75 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.,
Drug: Molidustat (BAY 85-3934)
Starting dose of 150 mg of BAY85-3934 as once-daily oral tablets. Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose. Total treatment time is 16 weeks. Planned doses include 15, 25, 50, 75, 100, 150 and 200 mg once daily
Drug: Molidustat (BAY 85-3934)
Starting dose at the subject's current weekly dose. Administered IV or SC 3 times per week. Doses will be titrated at the scheduled dose control visits according to the local label. Titration will be based on the subject's Hb response and tolerability of the prior dose. Epoetin alfa may be administered in either the United States (US) or Japan; epoetin beta will only be administered in Japan.
Biological: Epoetin alfa/beta
Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
Time frame: Baseline and weeks 14 to 17
Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
Time frame: From week 14 to 17
Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)
Time frame: From week 14 to 17
Change from baseline in Hb during active treatment
Time frame: Baseline and weeks 14 to 17
Number of patients with hemoglobin levels outside the target range
Time frame: From week 14 to 17
Dose level in the evaluation period
Time frame: Up to 16 weeks
Duration of exposure on each dose level
Time frame: Up to 16 weeks
Number of subjects requiring titration of dose
Time frame: Up to 16 weeks
Number of participants with serious adverse events as a measure of safety and tolerability
Time frame: Up to 16 weeks
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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