NCT01818687

Safety and Tolerability Study of MCI-196

A Multi-centre, Open-label Study Evaluating the Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Chronic Kidney Disease Stages 3b to 5 and With Hyperphosphataemia Not on Dialysis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety and tolerability of colestilan (MCI-196) in paediatric subjects (aged 2 years to \<18 years) with CKD stages 3b to 5, diagnosed with hyperphosphataemia, who are not on dialysis.

Detailed description

This study has been terminated because of insufficient patient recruitment. There were no safety concerns.

Conditions

• Chronic Kidney Disease
• Not on Dialysis
• Hyperphosphatemia
• Paediatric

Interventions

Type	Name	Description
DRUG	colestilan	body surface area equivalent (BSAeq) 3 g/day, 6 g/day, 9 g/day, 12 g/day or 15 g/day

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-03-26
• Last updated: 2015-05-27

Locations

1 site across 1 country: United Kingdom