A Phase 3 interventional study of colestilan-L and colestilan-M in Chronic Kidney Disease, Dialysis and Hyperphosphatemia, sponsored by Mitsubishi Tanabe Pharma Corporation. Terminated at 1 site in United Kingdom. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-05-27.
Sponsored by Mitsubishi Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Mitsubishi Tanabe Pharma Corporation is the lead sponsor of 40 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MCI-196 BSA eq 3g
Drug: colestilan-L
MCI-196 BSA eq 6g
Drug: colestilan-M
MCI-196 BSA eq 9g
Drug: colestilan-H
Calcium-based P binder
Drug: CBPB
body surface area equivalent (BSAeq) 3 g/day
Also known as: BindRen
BSAeq 6 g/day
Also known as: BindRen
BSAeq 9 g/day
Also known as: BindRen
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
This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Mitsubishi Tanabe Pharma Corporation