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

PHASE2CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

March 13, 2014

Primary Completion Date

October 19, 2016

Study Completion Date

November 16, 2016

Conditions
AnemiaRenal Insufficiency, Chronic
Interventions
DRUG

Molidustat (BAY85-3934)

Subjects will continue with the same treatment they were receiving in the parent study (16208). BAY85-3934 will be administered daily as oral tablets. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits, the dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose. Total treatment time is up to 36 months. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.

BIOLOGICAL

Epoetin alfa/beta

Subjects will continue with the same treatment they were receiving in the parent study (16208). Epoetin alfa / beta will be administered as intravenous (IV) or subcutaneous (SC) injections per individual subject regimen according to the local label. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits,dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose.Total treatment time is up to 36 months.

Trial Locations (26)

14215

Buffalo

33028

Pembroke Pines

34652

New Port Richey

43615

Toledo

45206

Cincinnati

48202

Detroit

63141

Creve Coeur

73116

Oklahoma City

75050

Grand Prairie

76063

Mansfield

76104

Fort Worth

76105

Fort Worth

76164

Fort Worth

77004

Houston

77091

Houston

90262

Lynwood

90602

Whittier

90606

Whittier

90813

Long Beach

91324

Northridge

91702

Azusa

91773

San Dimas

37212-8150

Nashville

050-0083

Muroran

511-0061

Kuwana

607-8116

Kyoto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY