Dose-finding Study of MCI-196

NCT01814904 | Terminated Phase 3 DMC

• 1 other identifier: MCI-196-E14
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean absolute change in serum phosphorus

  17 weeks

Secondary Outcomes (3)

• Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value)

  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)

  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)])

  17 weeks

Study Arms (4)

MCI-196-L

EXPERIMENTAL

MCI-196 BSA eq 3g

Drug: colestilan-L

MCI-196-M

EXPERIMENTAL

MCI-196 BSA eq 6g

Drug: colestilan-M

MCI-196-H

EXPERIMENTAL

MCI-196 BSA eq 9g

Drug: colestilan-H

CBPB

ACTIVE COMPARATOR

Calcium-based P binder

Drug: CBPB

Interventions

colestilan-L DRUG

body surface area equivalent (BSAeq) 3 g/day

Also known as: BindRen

MCI-196-L

colestilan-M DRUG

BSAeq 6 g/day

Also known as: BindRen

MCI-196-M

colestilan-H DRUG

BSAeq 9 g/day

Also known as: BindRen

MCI-196-H

CBPB DRUG

CBPB

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 2 years to \<18 years with CKD stage 5 on dialysis (haemodialysis or peritoneal dialysis) for at least one month
• The subject has a documented diagnosis of hyperphosphataemia, as demonstrated by serum phosphorus(P) levels above the age-related upper limit of normal KDOQI Clinical Practice Guidelines for Nutrition in Children with CKD updated 2008)
• The subject has been taking CBPB prior to enrolment into the study (i.e., prior to the screening visit)
• The subject must have demonstrated serum P levels \>1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the wash-out period (this must be demonstrated after stopping treatment with CBPB)
• At the time of randomisation, the subject must have demonstrated an increase in serum P levels from his/her most recent P central laboratory measurement by at least 10% above the pre-wash-out level

You may not qualify if:

• The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices)
• The subject was treated with a combination of two or more phosphate binders within one month prior to screening
• The subject cannot stop treatment (prescription or over-the counter) of any of the following orally taken medications during the wash-out period: any product containing calcium (Ca), magnesium (Mg), aluminium compounds, sevelamer, lanthanum, ketosteril
• The subject is receiving immunosuppressant treatment for any medical condition at the time of randomisation or is expected to receive such treatment during the course of the study
• The subject is considered unstable on his/her current treatment for CKD within one month prior to screening (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism \[i.e., serum P and Ca levels\])

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

London, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

GB (1)