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
DIALOGUE5
A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Long-term Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis in the United States and Japan
1 other identifier
interventional
88
2 countries
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2014
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedStudy Start
First participant enrolled
March 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2016
CompletedSeptember 20, 2019
September 1, 2019
2.6 years
February 14, 2014
September 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in local laboratory hemoglobin level from baseline
Baseline up to 36 months
Number of participants with serious adverse events as a measure of safety and tolerability
Up to 36 months
Secondary Outcomes (12)
Maintenance in hemoglobin target range (10.0 to 11.0 g/dL)
Up to 36 months
Maintenance in hemoglobin target range (9.5 to 11.5 g/dL)
Up to 36 months
Duration of treatment exposure
Up to 36 months
Number of subjects requiring titration of dose
Up to 36 months
Change of reticulocyte count from baseline of this study
Baseline up to 36 months
- +7 more secondary outcomes
Study Arms (2)
Molidustat (BAY85-3934)
EXPERIMENTALEpoetin alfa/beta
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Eligible male or female subjects were previously enrolled in Study 16208, have a diagnosis of anemia associated with CKD, and are on hemodialysis.
- Men who agree to use adequate contraception when sexually active or women without childbearing potential
- Participation and completion of treatment in Study 16208; subjects must have received 16 weeks of study medication and completed the end of treatment visit (Day 113) in the parent study
- Mean Hb concentration of 9.5 to 11.5 g/dL, inclusive, during the evaluation period (i.e., the last 4 weeks of the parent study) when the subject completed 16 weeks of treatment with BAY85-3934, epoetin alfa, or epoetin beta in Study 16208
You may not qualify if:
- A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
- Subjects treated with immunosuppressive therapy and the breast cancer resistant protein (BCRP) substrates, irinotecan, topotecan, methotrexate, imatinib, and lapatinib
- Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as mean BP ≥ 180/110 mmHg or systolic BP \< 95 mmHg, respectively
- Severe rhythm or conduction disorder (e.g., HR \< 50 or \> 110 bpm, atrial fibrillation or flutter, prolonged QT \> 500 msec, second or third degree atrioventricular \[AV\] block)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or gamma-glutamyl transferase \> 3 x the upper limit of norma \[ULN\], total bilirubin \> 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
- An ongoing SAE from Study 16208 that is assessed as related to study drug
- Alcohol or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (26)
Unknown Facility
Azusa, California, 91702, United States
Unknown Facility
Long Beach, California, 90813, United States
Unknown Facility
Lynwood, California, 90262, United States
Unknown Facility
Northridge, California, 91324, United States
Unknown Facility
San Dimas, California, 91773, United States
Unknown Facility
Whittier, California, 90602, United States
Unknown Facility
Whittier, California, 90606, United States
Unknown Facility
New Port Richey, Florida, 34652, United States
Unknown Facility
Pembroke Pines, Florida, 33028, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Creve Coeur, Missouri, 63141, United States
Unknown Facility
Buffalo, New York, 14215, United States
Unknown Facility
Cincinnati, Ohio, 45206, United States
Unknown Facility
Toledo, Ohio, 43615, United States
Unknown Facility
Oklahoma City, Oklahoma, 73116, United States
Unknown Facility
Nashville, Tennessee, 37212-8150, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Fort Worth, Texas, 76105, United States
Unknown Facility
Fort Worth, Texas, 76164, United States
Unknown Facility
Grand Prairie, Texas, 75050, United States
Unknown Facility
Houston, Texas, 77004, United States
Unknown Facility
Houston, Texas, 77091, United States
Unknown Facility
Mansfield, Texas, 76063, United States
Unknown Facility
Muroran, Hokkaido, 050-0083, Japan
Unknown Facility
Kuwana, Mie-ken, 511-0061, Japan
Unknown Facility
Kyoto, 607-8116, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 17, 2014
Study Start
March 13, 2014
Primary Completion
October 19, 2016
Study Completion
November 16, 2016
Last Updated
September 20, 2019
Record last verified: 2019-09