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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/NCT00542815
Registration number
NCT00542815
Ethics application status
Date submitted
10/10/2007
Date registered
12/10/2007
Date last updated
2/10/2014
Titles & IDs
Public title
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
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Scientific title
A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
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Secondary ID [1]
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MCI-196-E10
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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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0
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Dialysis
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Hyperphosphatemia
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Renal and Urogenital
0
0
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0
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Other renal and urogenital disorders
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Metabolic and Endocrine
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0
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0
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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
Treatment: Drugs - Another Phosphate binder (Sevelamer)
Experimental: 1 -
Active Comparator: 2 -
Treatment: Drugs: MCI-196
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
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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The Change in Serum Phosphorus for MCI-196 and Sevelamer
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Assessment method [1]
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Change from Baseline to Week 52 (LOCF)
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Timepoint [1]
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52 weeks (Baseline-52 weeks)
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Secondary outcome [1]
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The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
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Assessment method [1]
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Percent Change from Baseline to Week 52 (LOCF)
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Timepoint [1]
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52 weeks (Baseline-52 weeks)
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Eligibility
Key inclusion criteria
- Clinically stable haemodialysis or peritoneal dialysis treatment.
- Stable phosphate control
- Stabilised phosphorus diet.
- female subjects of child-bearing potential must have a negative serum pregnancy test.
- Male subjects must agree to use appropriate contraception.
- Completed one of the MCI-196 PIII studies
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Minimum age
No limit
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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.
- Current or a history of significant gastrointestinal motility problems
- Positive test for HIV 1 and 2 antibodies.
- History of substance or alcohol abuse within the last year.
- Seizure disorders.
- History of drug or other allergy.
- Temporary catheter with active signs of inflammation or infection.
- The subject has participated in a clinical study with any experimental medication
(with the exception of MCI-196 PIII studies) in the last 30days or experimental
biological product within the 90 days prior to signing of informed consent form.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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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
1/11/2007
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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
1/08/2010
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Sample size
Target
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Accrual to date
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Final
632
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Recruitment in Australia
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Austria
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Graz
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Stevenage
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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 PIII multi-center, open-label, flexible dose, long-term safety study, that in
conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will
allow exposure to MCI-196 for up to 52 weeks
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00542815
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Information at Mitsubishi Pharma Europe
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00542815
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