Dose-finding Study of MCI-196

NCT ID: NCT01814904

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-01-31

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.

Detailed Description

This study has been terminated because of insufficient patient recruitment. There were no safety concerns.

Conditions

Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Paediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MCI-196-L

MCI-196 BSA eq 3g

Group Type: EXPERIMENTAL

colestilan-L

Intervention Type: DRUG

body surface area equivalent (BSAeq) 3 g/day

MCI-196-M

MCI-196 BSA eq 6g

Group Type: EXPERIMENTAL

colestilan-M

Intervention Type: DRUG

BSAeq 6 g/day

MCI-196-H

MCI-196 BSA eq 9g

Group Type: EXPERIMENTAL

colestilan-H

Intervention Type: DRUG

BSAeq 9 g/day

CBPB

Calcium-based P binder

Group Type: ACTIVE_COMPARATOR

CBPB

Intervention Type: DRUG

Interventions

colestilan-L

body surface area equivalent (BSAeq) 3 g/day

Intervention Type: DRUG

colestilan-M

BSAeq 6 g/day

Intervention Type: DRUG

colestilan-H

BSAeq 9 g/day

Intervention Type: DRUG

CBPB

Intervention Type: DRUG

Other Intervention Names

BindRen; BindRen; BindRen

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices)
• The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or severe gastrointestinal [GI] disorders such as chronic or severe constipation [as judged by the Investigator], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery)
• 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])

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

MCI-196-E14

Identifier Type: -

Identifier Source: org_study_id