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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
MCI-196-E07
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Hyperphosphatemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) - 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.
Timepoint [1] 0 0
week16 minus week12
Secondary outcome [1] 0 0
Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) - 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.
Timepoint [1] 0 0
week12 minus week0

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Nedlands
Recruitment hospital [3] 0 0
- Parkville
Recruitment hospital [4] 0 0
- St Leonards
Recruitment hospital [5] 0 0
- Sydney
Recruitment hospital [6] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment postcode(s) [4] 0 0
- St Leonards
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Frydek-Mistek
Country [3] 0 0
Czech Republic
State/province [3] 0 0
HradecKralove
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Ostrava
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Czech Republic
State/province [5] 0 0
Praha
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Tabor
Country [7] 0 0
Czech Republic
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Usti nad Labem
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
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France
State/province [9] 0 0
Montpelier
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France
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Paris
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Germany
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Aachen
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Germany
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Aschaffenburg
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Germany
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Coburg
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Germany
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Coesfeld
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Germany
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Darmstadt
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Germany
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Dieburg
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Dortmund
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Dusseldorf
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Hamburg
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Homberg - Efze
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Langen
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Germany
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Mannheim-Kafertal
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Germany
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Munchen
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Germany
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Potsdam-Babelsberg
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Hungary
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Baja
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Hungary
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Budapest
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Hungary
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Kisvarda
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Hungary
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Veszprem
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Italy
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Biella
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Italy
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Como
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Italy
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Cremona
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Italy
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Lecco
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Italy
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Livorno
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Italy
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Milan
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Pavia
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Italy
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Perugia
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Rome
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Ciechanow
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Czestochowa
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Gdansk
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Krakow
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Lodz
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Lublin
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Oswiecim
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Pabianice
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Rybnik
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Sokolow Podlaski
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Starogard Gdanski
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Warszawa
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Wejherowo
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Zgierz
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Durban
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Gauteng
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South Africa
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Johannesburg
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South Africa
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Port Elizabeth
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Spain
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Barcelona
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Oviedo
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Spain
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Sevilla
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United Kingdom
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Glasgow
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United Kingdom
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Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mitsubishi Tanabe Pharma Corporation
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00416520
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Professor
Address 0 0
Information at Mitsubishi Pharma Europe
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications