NCT02133404

A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

Phase II Study of ASP7991 -A Double-blind, Cinacalcet Hydrochloride-controlled, Dose-ascending Study in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis -

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis

Detailed description

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.

Conditions

• Secondary Hyperparathyroidism

Interventions

Type	Name	Description
DRUG	ASP7991	oral
DRUG	Cinacalcet	oral
DRUG	Placebo	oral

Timeline

• Start date: 2014-03-14
• Primary completion: 2014-11-10
• Completion: 2014-11-10
• First posted: 2014-05-08
• Last updated: 2024-11-06

Locations

6 sites across 1 country: Japan