Clinical Trial: A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of ASP7991 -A Double-blind, Cinacalcet Hydrochloride-controlled, Dose-ascending Study in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis -
Brief Summary: To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis
Detailed Summary:
This study is a multicenter, double-blind, randomized, Cinacalcet hydrochloride-controlled, parallel-group, dose-ascending study. Subjects judged to be eligible will be registered and randomized into either ASP7991 group (receiving ASP7991 and cinacalcet-placebo) or Cinacalcet group (receiving cinacalcet and ASP7991-placebo), and will receive 12-week (84 days) administration of study drug from first dialysis day in a week (treatment period), in a double-blind manner. The dose of the study drugs will be increased every 3 weeks in dose-ascending manner.
Follow-up assessment will be performed before starting first dialysis in a week, 1 week (7 days) after the completion of the treatment period.
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Serum iPTH concentration [ Time Frame: Before and at 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Corrected serum Ca, Phosphate(P) concentration [ Time Frame: Before and at 3, 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment ]Ca x P will be calculated
- serum vitamin D concentration [ Time Frame: Before and at 22, 43, 64, 85 and 92 days after start of the treatment ]
- serum wPTH concentration [ Time Frame: Before and at 22, 43, 64, 85 and 92 days after start of the treatment ]wPTH: whole parathyroid hormone
- Serum concentration of bone metabolism markers [ Time Frame: Before and at 22, 43, 64, 85 and 92 days after start of the treatment ]Bone metabolism markers will be BAP (Bone specific alkaline phosphatase) and TRACP5b (Tartrate-resistant acid phosphatase-5b)
- Serum FGF23 concentration [ Time Frame: Before and at 22, 43, 64, 85 and 92 days after start of the treatment ]
- Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: For 12 weeks after start of treatment ]
Original Secondary Outcome: Same as current
Information By: Astellas Pharma Inc
Dates:
Date Received: April 29, 2014
Date Started: March 2014
Date Completion:
Last Updated: November 26, 2014
Last Verified: November 2014