Dose-finding Study of MCI-196

NCT01814904 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-05-27

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Mitsubishi Tanabe Pharma Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814904 on ClinicalTrials.gov