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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00416520
Registration number
NCT00416520
Ethics application status
Date submitted
27/12/2006
Date registered
28/12/2006
Date last updated
4/11/2014
Titles & IDs
Public title
A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
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Scientific title
A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
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Secondary ID [1]
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MCI-196-E07
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease
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Hyperphosphatemia
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
Treatment: Drugs - Placebo
Treatment: Drugs - Another phosphate binder (Sevelamer)
Experimental: 1 -
Placebo Comparator: 2 -
Active Comparator: 3 -
Treatment: Drugs: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind
Treatment: Drugs: Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
Treatment: Drugs: Another phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
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Assessment method [1]
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ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.
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Timepoint [1]
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week16 minus week12
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Secondary outcome [1]
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Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)
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Assessment method [1]
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ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.
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Timepoint [1]
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week12 minus week0
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Eligibility
Key inclusion criteria
- Male or female, 18 years of age or over
- Clinically stable haemodialysis or peritoneal dialysis
- Stable phosphate control
- On a stabilised phosphorus diet
- Female and of child-bearing potential have a negative serum pregnancy test.
- Male subjects must agree to use appropriate contraception.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Current clinically significant medical comorbidities, which may substantially
compromise subject safety, or expose them to undue risk, or interfere significantly
with study procedures and which, in the opinion of the Investigator, makes the subject
unsuitable for inclusion in the study.
- Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
- A current or history of significant gastrointestinal motility problems
- A positive test for HIV 1 and 2 antibodies
- A history of substance or alcohol abuse within the last year.
- Seizure disorders
- A history of drug or other allergy
- A temporary catheter as a vascular access
- Participated in a clinical study with any experimental medication in the last 30 days
or an experimental biological product within the last 90 days prior to signing of
informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2009
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Sample size
Target
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Accrual to date
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Final
336
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Nedlands
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- Parkville
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- St Leonards
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- Sydney
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Recruitment hospital [6]
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- Woolloongabba
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- Adelaide
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- Nedlands
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- Parkville
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- St Leonards
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- Sydney
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Recruitment postcode(s) [6]
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- Woolloongabba
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Recruitment outside Australia
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Austria
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Graz
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Czech Republic
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Mitsubishi Tanabe Pharma Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase III multi-centre study in three periods: the first period is a phosphate
binder washout for 4 weeks, the second period is an open-label, randomised, parallel group,
flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with
placebo for 4 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00416520
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Professor
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Address
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Information at Mitsubishi Pharma Europe
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00416520
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