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Outcome Measures

Primary Outcomes (2)

The mean Hb level during the evaluation period
From week 33 to 36
The change in mean Hb level during the evaluation period from baseline
Baseline and week 33 to 36

Secondary Outcomes (15)

Responder rate: proportion of responders among the subjects
From week 33 to 36
Proportion of subjects who meet each component of the response
From week 33 to 36
Hb level
Up to 52 weeks
Change in Hb level
Baseline and up to 52 weeks
Proportion of subjects whose mean hemoglobin level is in the target range
From week 33 to 36
+10 more secondary outcomes

Study Arms (2)

Molidustat group

EXPERIMENTAL

Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo.

Drug: Molidustat (BAY85-3934)Drug: Placebo of Darbepoetin alfa

Darbepoetin alfa group

ACTIVE COMPARATOR

Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.

Drug: Darbepoetin alfaDrug: Placebo of Molidustat (BAY85-3934)

Interventions

Molidustat (BAY85-3934)Drug

Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).

Molidustat group

Darbepoetin alfaDrug

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.

Darbepoetin alfa group

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization
Body weight (after dialysis) \> 40 and ≤ 160 kg at screening

Study Sites (53)

Hakuyoukai Medical corporation Hakuyoukai Hospital

Nagoya, Aichi-ken, 465-0025, Japan

Shinkashiwa Clinic

Kashiwa, Chiba, 277-0084, Japan

Kisarazu Clinic

Kisarazu, Chiba, 292-0805, Japan

Kuwajima Clinic

Niihama, Ehime, 792-0812, Japan

Sabae kidney Clinic

Sabae, Fukui, 916-0044, Japan

Houshikai Kano hospital

Kasuya-gun, Fukuoka, 811-0120, Japan

Saiseikai Yahata General Hospital

Kitakyushu, Fukuoka, 805-0050, Japan

Related Publications (2)

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

PMID: 36005278DERIVED

Akizawa T, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Yamamoto H. Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies. BMJ Open. 2019 Jun 14;9(6):e026602. doi: 10.1136/bmjopen-2018-026602.

PMID: 31203241DERIVED

MeSH Terms

Conditions

AnemiaRenal Insufficiency, Chronic

Interventions

molidustatDarbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic Disease

Maintenance Treatment of Renal Anemia in Dialysis Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (15)

Study Arms (2)

Molidustat group

Darbepoetin alfa group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (53)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (15)

Study Arms (2)

Molidustat group

Darbepoetin alfa group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (53)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations