Dose-finding Study of MCI-196
NCT01814904 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2015-05-27
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
- Chronic Kidney Disease
- Dialysis
- Hyperphosphatemia
- Paediatric
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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