check_circleStudy Completed
Anemia, Renal Insufficiency, Chronic
Bayer Identifier:
16208
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
BothAge
18 - N/ATrial summary
Enrollment Goal
201Trial Dates
October 2013 - December 2015Phase
Phase 2Could I Receive a placebo
NoProducts
Molidustat (BAY85-3934)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Philadelphia, 19104, United States | |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Withdrawn | Baton Rouge, 70806, United States | |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Withdrawn | Tempe, 85284, United States | |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Withdrawn | Kalamazoo, 49007, United States | |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Withdrawn | Kanagawa, 210-0024, Japan | |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Withdrawn | Phoenix, 85027, United States | |
Withdrawn | Las Vegas, 89128, United States | |
Withdrawn | Glendale, 85301, United States | |
Withdrawn | Morgantown, 26505, United States | |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 perioddate_rangeTime Frame:Baseline and weeks 14 to 17enhanced_encryptionNoSafety Issue:
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 17enhanced_encryptionNoSafety Issue:
- Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)date_rangeTime Frame:From week 14 to 17enhanced_encryptionNoSafety Issue:
- Change from baseline in Hb during active treatmentdate_rangeTime Frame:Baseline and weeks 14 to 17enhanced_encryptionNoSafety Issue:
- Number of patients with hemoglobin levels outside the target rangedate_rangeTime Frame:From week 14 to 17enhanced_encryptionNoSafety Issue:
- Dose level in the evaluation perioddate_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
- Duration of exposure on each dose leveldate_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
- Number of subjects requiring titration of dosedate_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
- Number of participants with serious adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 16 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
5