Long-term Pre-dialysis Extension in Europe and Asia Pacific

Launched by BAYER · Feb 4, 2014

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Men who agree to use adequate contraception when sexually active or women without childbearing potential
• • Not on dialysis at study entry
• • Serum ferritin levels ≥ 100 μg/L and \< 1000 μg/L or transferrin saturation ≥ 20%
• • Inclusion criteria for inclusion into the Hb Stabilization (HbS) Phase: Requires Hb stabilization (at 10.0 to 12..0g/dL for a minimum of 4 weeks) as follows: Received BAY 85-3934 and reached a stopping event in Study 15141 or received placebo and reached a stopping event in Study 15141 or completed 16 weeks of treatment with BAY 85-3934 in Study 15141or 15261 but had mean Hb during the evaluation period outside the target range of 10.0 to 12.0 g/dL, or Completed 16 weeks of treatment with placebo in Study 15141 and was re-assessed at 4 weeks after end of study as eligible for Study 15653 (this study)
• • Inclusion criteria for inclusion into the Main Phase: Mean Hb concentration of 10.0 to 12.0 g/dL who completed 16 weeks of treatment (BAY85-3934 arm) in Study 15141, or completed 16 weeks of treatment (BAY-3934 or darbepoetin arm)in study 15261 without a dose suspension lasting \> 6 consecutive weeks, or mean Hb concentration of 10.0 to 12.0g/dL during the HbS phase of Study 15653 for a minimum of 4 weeks after visit 3.
• 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)
• • Red blood cell (RBC) containing transfusion within the 8 weeks before baseline
• • Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates
• • Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure ≥ 180/110 mmHg or systolic blood pressure \< 95 mmHg, respectively
• • Severe rhythm or conduction disorders (e.g., heart rate \[HR\] \< 50 or \> 110 bpm, atrial flutter, prolonged QT \> 500 msec, second or third degree atrioventricular \[AV\] block), if not reacted with a pace marker)
• • New York Heart Association Class III or IV congestive heart failure
• • Severe hepatic insufficiency (defined as alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]\>3x the upper limit of normal \[ULN\], total bilirubin \> 2 mg/dL, or Child Pugh B or C) or active hepatitis, in the investigator's opinion
• • An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug