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A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:
A Dose Escalation Study of VS-505 to Evaluate the Tolerability, Safety and Efficacy in End Stage Renal Disease Patients Undergoing Hemodialysis

Clinical Trial Summary

The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with meal for 8 weeks to hemodialysis patients with hyperphosphatemia

Clinical Trial Description

This study consists of 4 period; 1) screening period: up to 30 days, 2) first washout period: 2 weeks (remove existing phosphate binder effect), 3) treatment period: 8 weeks, and 4) second washout period: 2 weeks (remove VS-505 effect). VS-505 is orally administered with meal for 8 weeks. The starting dose of VS-505 is 1.50 g/day and the dose will be elevated step wise from 1.50 g to 2.25 g, 4.50 g and 6.75 g per day based on the safety assessment and plasma Pi level every 2 weeks during the treatment period. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02469467
Study type Interventional
Source KDL Inc.
Contact KDL inc
Phone +81-3-3234-3400
Email asao@kdl-japan.com
Status Recruiting
Phase Phase 1/Phase 2
Start date June 2015
Completion date December 2016
View Details
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