NCT02469467

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: KDL Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• End Stage Renal Disease
• Hyperphosphatemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	VS-505	VS-505 is orally administered with meal for 8 weeks

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2015-06-11
• Last updated: 2016-02-08

Locations

1 site across 1 country: Australia