Clinical Trial: Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Dose Range-finding Study of ASP1585 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

Brief Summary: The objective of this study is to examine the clinical dose range of ASP1585 based on the efficacy, safety, and feasibility of treatment in chronic kidney disease patients on hemodialysis with hyperphosphatemia.

Detailed Summary:
Sponsor: Astellas Pharma Inc

Current Primary Outcome:

  • Change from the baseline of serum phosphorus level [ Time Frame: Baseline and Week 6 ]
  • Safety assessed by AEs [ Time Frame: Up to 6 weeks after the study drug dosing ]
  • Safety assessed by Hematology test [ Time Frame: Up to 6 weeks after the study drug dosing ]
  • Safety assessed by Blood biochemistry tests [ Time Frame: Up to 6 weeks after the study drug dosing ]
  • Safety assessed by Blood cogulability tests [ Time Frame: Up to 6 weeks after the study drug dosing ]
  • Blood concentration of Vitamin [ Time Frame: Up to 6 weeks after the study drug dosing ]
  • Safety assessed by Vital signs [ Time Frame: Up to 6 weeks after the study drug dosing ]
    Systolic blood pressure, diastolic blood pressure, heart rate
  • Safety assessed by bowel movement [ Time Frame: Up to 6 weeks after the study drug dosing ]
  • Safety assessed by ECG [ Time Frame: Up to 6 weeks after the study drug dosing ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time course of serum phosphorus level [ Time Frame: Up to Week 6 ]
  • Time course of corrected serum calcium level [ Time Frame: Up to Week 6 ]
  • Time course of calcium-phosphorus product [ Time Frame: Up to Week 6 ]
  • Time course of intact parathyroid hormone [ Time Frame: Up to Week 6 ]
  • Percentage of subjects who achieved the target serum phosphorus level (3.5 to 6.0 mg/dL) [ Time Frame: Up to Week 6 ]
  • Time achievement of the target serum phosphorus level (3.5 to 6.0 mg/dL) [ Time Frame: Up to Week 6 ]


Original Secondary Outcome: Same as current

Information By: Astellas Pharma Inc

Dates:
Date Received: March 3, 2016
Date Started: January 2008
Date Completion:
Last Updated: June 17, 2016
Last Verified: April 2016