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.
This study has been terminated because of insufficient patient recruitment. There were no safety concerns.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
body surface area equivalent (BSAeq) 3 g/day
BSAeq 6 g/day
BSAeq 9 g/day
Investigational site
London, United Kingdom
Mean absolute change in serum phosphorus
Time frame: 17 weeks
Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value)
Kidney Disease Outcomes Quality Initiative(KDOQI)
Time frame: 17 weeks
Mean absolute change in efficacy laboratory parameters (i.e.,P, Ca, Ca P ion product [CaxP], intact parathyroid hormone [iPTH], serum glucose, glycosylated haemoglobin [HbA1c], and uric acid)
Time frame: 17 weeks
Mean percentage change in other efficacy laboratory parameters (i.e., lipid parameters [low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol, and triglycerides (TG)])
Time frame: 17 weeks
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