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Last Updated: August 14, 2020

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CLINICAL TRIALS PROFILE FOR MOLIDUSTAT

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Clinical Trials for Molidustat

Trial ID Title Status Sponsor Phase Summary
NCT01679587 Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD) Completed Bayer Phase 1 Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat, exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide, vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine monophosphate, and noradrenaline
NCT01975818 Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 Completed Bayer Phase 2 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
NCT02064426 Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 Active, not recruiting Bayer Phase 2 Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.
NCT02312973 To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects Completed Bayer Phase 1 The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.
NCT03350321 A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects Not yet recruiting Bayer Phase 3 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).
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Molidustat

Condition Name

Condition Name for
Intervention Trials
Anemia and Renal Insufficiency, Chronic 5
Renal Insufficiency, Chronic 3
Anemia 2
Kidney Diseases 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Renal Insufficiency, Chronic 9
Renal Insufficiency 8
Anemia 7
Kidney Diseases 3
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Clinical Trial Locations for Molidustat

Trials by Country

Trials by Country for
Location Trials
Japan 99
United States 27
Germany 5
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Trials by US State

Trials by US State for
Location Trials
Texas 2
Tennessee 2
Pennsylvania 2
Oklahoma 2
Ohio 2
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Clinical Trial Progress for Molidustat

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 5
Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 3
Completed 3
Recruiting 2
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Clinical Trial Sponsors for Molidustat

Sponsor Name

Sponsor Name for
Sponsor Trials
Bayer 9
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 9
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