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Dose-finding Study of MCI-196

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT01814904
Collaborator
(none)
10
Enrollment
1
Location
4
Arms
9
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-centre, Randomised, Controlled, Parallel Group, Open-label Study Evaluating the Efficacy, Safety and Tolerability of Three Doses of Colestilan (MCI-196) Compared to Standard Therapy With a Calcium-based Phosphate Binder, in Paediatric Subjects With Chronic Kidney Disease Stage 5 on Dialysis and With Hyperphosphataemia
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: MCI-196-L

MCI-196 BSA eq 3g

Drug: colestilan-L
body surface area equivalent (BSAeq) 3 g/day
Other Names:
  • BindRen

    		•
    Experimental: MCI-196-M

    MCI-196 BSA eq 6g

    Drug: colestilan-M
    BSAeq 6 g/day
    Other Names:
  • BindRen

    		•
    Experimental: MCI-196-H

    MCI-196 BSA eq 9g

    Drug: colestilan-H
    BSAeq 9 g/day
    Other Names:
  • BindRen

    		•
    Active Comparator: CBPB

    Calcium-based P binder

    Drug: CBPB

    Outcome Measures

    Primary Outcome Measures

    1. Mean absolute change in serum phosphorus [17 weeks]

    Secondary Outcome Measures

    1. 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]

      Kidney Disease Outcomes Quality Initiative(KDOQI)

    2. 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]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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])

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational site London United Kingdom

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT01814904
    Other Study ID Numbers:
    • MCI-196-E14
    First Posted:
    Mar 20, 2013
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Hyperphosphatemia
    Bile Acids and Salts

    Study Results

    No Results Posted as of May 27, 2015