check_circleStudy Completed

Anemia, Renal Insufficiency, Chronic

Maintenance treatment of anemia associated with chronic kidney disease (CKD) in hemodialysis subjects on epoetin alfa / beta treatment versus BAY85-3934

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
201
Trial Dates
October 2013 - December 2015
Phase
Phase 2
Could I Receive a placebo
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Cincinnati, 45206, United States
Completed
San Dimas, 91773, United States
Completed
Azusa, 91702, United States
Completed
San Antonio, 78215, United States
Completed
Nashville, 37212-8150, United States
Completed
Los Angeles, 90025, United States
Withdrawn
Philadelphia, 19104, United States
Completed
Whittier, 90602, United States
Completed
Brooklyn, 11212, United States
Completed
Fresh Meadows, 11365, United States
Withdrawn
Baton Rouge, 70806, United States
Completed
Buffalo, 14215, United States
Completed
Detroit, 48202, United States
Completed
Eatontown, 07724, United States
Withdrawn
Tempe, 85284, United States
Completed
Toledo, 43615, United States
Completed
New Port Richey, 34652, United States
Withdrawn
Kalamazoo, 49007, United States
Completed
Nagano, 388-8004, Japan
Completed
Kyoto, 607-8116, Japan
Completed
Muroran, 050-0083, Japan
Withdrawn
Kanagawa, 210-0024, Japan
Completed
Himeji, 670-0947, Japan
Completed
Houston, 77091, United States
Withdrawn
Phoenix, 85027, United States
Withdrawn
Las Vegas, 89128, United States
Withdrawn
Glendale, 85301, United States
Withdrawn
Morgantown, 26505, United States
Completed
Mansfield, 76063, United States
Completed
Fort Worth, 76105, United States
Completed
Fort Worth, 76104, United States
Completed
Fort Worth, 76164, United States
Completed
Northridge, 91324, United States
Completed
Kuwana, 511-0061, Japan
Completed
Oklahoma City, 73116, United States
Completed
San Antonio, 78229, United States
Completed
Detroit, 48236, United States
Completed
Pembroke Pines, 33028, United States
Completed
Creve Coeur, 63141, United States
Completed
Long Beach, 90813, United States
Completed
Houston, 77004, United States
Completed
Lynwood, 90262, United States
Completed
Whittier, 90606, United States
Completed
Grand Prairie, 75050, United States
Withdrawn
San Antonio, 78207, United States
Withdrawn
San Antonio, 78224, United States

Primary Outcome

  • Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
    date_rangeTime Frame:
    Baseline and weeks 14 to 17
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
    date_rangeTime Frame:
    From week 14 to 17
    enhanced_encryption
    Safety Issue:
    No
  • Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)
    date_rangeTime Frame:
    From week 14 to 17
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Hb during active treatment
    date_rangeTime Frame:
    Baseline and weeks 14 to 17
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with hemoglobin levels outside the target range
    date_rangeTime Frame:
    From week 14 to 17
    enhanced_encryption
    Safety Issue:
    No
  • Dose level in the evaluation period
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of exposure on each dose level
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects requiring titration of dose
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 16 weeks
    enhanced_encryption
    Safety Issue:
    No

Trial design

A randomized, parallel group, open-label, multicenter study to investigate the efficacy and safety of oral BAY85-3934 and active comparator (epoetin alfa / beta) in the maintenance treatment of subjects with anemia associated with chronic kidney disease who are on dialysis and on treatment with an erythropoiesis-stimulating agent in the United States and Japan
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
5