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TerminatedNCT01814904Updated May 27, 2015

Dose-finding Study of MCI-196

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

Why this study was terminated
This study has been terminated because of insufficient patient recruitment.
Phase
Phase 3
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
2 Years to 18 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Chronic Kidney Disease
  • Dialysis
  • Hyperphosphatemia
  • Paediatric
03

In context

Kidney Diseases

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
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

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])
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    MCI-196-L

    MCI-196 BSA eq 3g

    Drug: colestilan-L

  • Experimental
    MCI-196-M

    MCI-196 BSA eq 6g

    Drug: colestilan-M

  • Experimental
    MCI-196-H

    MCI-196 BSA eq 9g

    Drug: colestilan-H

  • Active comparator
    CBPB

    Calcium-based P binder

    Drug: CBPB

Interventions

  • Drugcolestilan-L

    body surface area equivalent (BSAeq) 3 g/day

    Also known as: BindRen

  • Drugcolestilan-M

    BSAeq 6 g/day

    Also known as: BindRen

  • Drugcolestilan-H

    BSAeq 9 g/day

    Also known as: BindRen

  • DrugCBPB
06

What researchers measure

Primary outcomes

  1. Mean absolute change in serum phosphorus

    Time frame: 17 weeks

Secondary outcomes

  1. 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

  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)

    Time frame: 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)])

    Time frame: 17 weeks

07

Study locations

1 site
  • Investigational site
    London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01814904
Lead sponsor
Mitsubishi Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Mar 20, 2013
Start date
Apr 2014
Primary completion
Jan 2015
Completion
Jan 2015
Last update
May 27, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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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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