Clinical trial NCT02064426: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Renal Insufficiency, Chronic
Keywords: Anemia of CKD on dialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
* Updates to medical and surgical history which meet the exclusion criteria in the parent study
* 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

Primary outcomes:
measure: Change in local laboratory hemoglobin level from baseline
timeFrame: Baseline up to 36 months
measure: Number of participants with serious adverse events as a measure of safety and tolerability
timeFrame: Up to 36 months
Secondary outcomes:
measure: Maintenance in hemoglobin target range (10.0 to 11.0 g/dL)
timeFrame: Up to 36 months
measure: Maintenance in hemoglobin target range (9.5 to 11.5 g/dL)
timeFrame: Up to 36 months
measure: Duration of treatment exposure
timeFrame: Up to 36 months
measure: Number of subjects requiring titration of dose
timeFrame: Up to 36 months
measure: Change of reticulocyte count from baseline of this study
timeFrame: Baseline up to 36 months
measure: Change of reticulocyte count from baseline of study 16208
timeFrame: Baseline up to 36 months
measure: Change of red blood cell count from baseline of this study
timeFrame: Baseline up to 36 months
measure: Change of red blood cell count from baseline of study 16208
timeFrame: Baseline up to 36 months
measure: Change of hematocrit from baseline of this study
timeFrame: Baseline up to 36 months
measure: Change of hematocrit from baseline of study 16208
timeFrame: Baseline up to 36 months
measure: Change of central laboratory hemoglobin level from baseline of this study
timeFrame: Baseline up to 36 months
measure: Change of central laboratory hemoglobin level from baseline of study 16208
timeFrame: Baseline up to 36 months
Other outcomes:
Locations:
city: Azusa
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Lynwood
country: United States
state: California
city: Northridge
country: United States
state: California
city: San Dimas
country: United States
state: California
city: Whittier
country: United States
state: California
city: Whittier
country: United States
state: California
city: New Port Richey
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Detroit
country: United States
state: Michigan
city: Creve Coeur
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Grand Prairie
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Mansfield
country: United States
state: Texas
city: Muroran
country: Japan
state: Hokkaido
city: Kuwana
country: Japan
state: Mie
city: Kyoto
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: