NCT01814904

Dose-finding Study of MCI-196

A Multi-centre, Randomised, Controlled, Parallel Group, Open-label Study Evaluating the Efficacy, Safety and Tolerability of Three Doses of Colestilan (MCI-196) Compared to Standard Therapy With a Calcium-based Phosphate Binder, in Paediatric Subjects With Chronic Kidney Disease Stage 5 on Dialysis and With Hyperphosphataemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The Primary Objective of this study is to determine the initial starting doses of colestilan (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with Hyperphosphataemia.

Detailed description

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

Conditions

• Chronic Kidney Disease
• Dialysis
• Hyperphosphatemia
• Paediatric

Interventions

Type	Name	Description
DRUG	colestilan-L	body surface area equivalent (BSAeq) 3 g/day
DRUG	colestilan-M	BSAeq 6 g/day
DRUG	colestilan-H	BSAeq 9 g/day
DRUG	CBPB

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-03-20
• Last updated: 2015-05-27

Locations

1 site across 1 country: United Kingdom