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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00542386 |
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Date of registration:
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10/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
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Scientific title:
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A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups) |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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642 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00542386 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Former Serbia and Montenegro
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Hungary
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Italy
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Macedonia, The Former Yugoslav Republic of
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Malaysia
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Poland
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Russian Federation
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Serbia
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Ukraine
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Contacts
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Name:
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Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Information at Mitsubishi Pharma Europe |
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Key inclusion & exclusion criteria
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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
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.
- A a serum albumin level<30.0g/L
- A PTH level >1000pg/mL
- A body mass index (BMI)<= 16.0kg/? or =>40.0kg/?
- A serum LDL-C level >4.94mmol/L(190mg/dL)
- A serum triglycerides level >6.76mmol/L (600mg/dL)
- A 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dialysis
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Chronic Kidney Disease
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Hyperphosphatemia
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Dyslipidemia
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Intervention(s)
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Drug: MCI-196
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Drug: Placebo
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Primary Outcome(s)
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The Change in LDL-cholesterol
[Time Frame: 12 weeks]
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The Change in Serum Phosphorus
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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The Change in Ca
[Time Frame: 12 weeks]
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The Incidence of Adverse Events
[Time Frame: 12 weeks]
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The Change in Total-cholesterol
[Time Frame: 12 weeks]
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The Change in Triglycerides
[Time Frame: 12 weeks]
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The Change in HDL-cholesterol
[Time Frame: 12 weeks]
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The Change in PTH
[Time Frame: 12 weeks]
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The Change in Ca x P Ion Product
[Time Frame: 12 weeks]
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Secondary ID(s)
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MCI-196-E08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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