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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
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
Secondary ID [1] 0 0
MCI-196-E10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Dialysis 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
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Change in Serum Phosphorus for MCI-196 and Sevelamer
Timepoint [1] 0 0
52 weeks (Baseline-52 weeks)
Secondary outcome [1] 0 0
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
Timepoint [1] 0 0
52 weeks (Baseline-52 weeks)

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
Minimum age
No limit
Maximum age
No limit
Sex
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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
632
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Austria
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Graz
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Czech Republic
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Frydek-Mistek
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Czech Republic
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Hradec Kralove
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Czech Republic
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Ostrava
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Czech Republic
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Praha
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Czech Republic
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Tabor
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Czech Republic
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Usti nad Labem
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France
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Bordeaux
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France
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Montpelier
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Zhytomyr
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Glasgow
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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 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00542815
Trial related presentations / publications
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

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