- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01814904
Dose-finding Study of MCI-196
May 25, 2015 updated by: Mitsubishi Tanabe Pharma Corporation
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
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.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
This study has been terminated because of insufficient patient recruitment.
There were no safety concerns.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom
- Investigational Site
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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])
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MCI-196-L
MCI-196 BSA eq 3g
|
body surface area equivalent (BSAeq) 3 g/day
Other Names:
|
Experimental: MCI-196-M
MCI-196 BSA eq 6g
|
BSAeq 6 g/day
Other Names:
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Experimental: MCI-196-H
MCI-196 BSA eq 9g
|
BSAeq 9 g/day
Other Names:
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Active Comparator: CBPB
Calcium-based P binder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean absolute change in serum phosphorus
Time Frame: 17 weeks
|
17 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value)
Time Frame: 17 weeks
|
Kidney Disease Outcomes Quality Initiative(KDOQI)
|
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
|
17 weeks
|
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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
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17 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
March 18, 2013
First Submitted That Met QC Criteria
March 18, 2013
First Posted (Estimate)
March 20, 2013
Study Record Updates
Last Update Posted (Estimate)
May 27, 2015
Last Update Submitted That Met QC Criteria
May 25, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCI-196-E14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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