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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00806481 |
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Date of registration:
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25/06/2008 |
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Primary sponsor: |
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Public title:
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Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease
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Scientific title:
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Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease? |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00806481 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Charles J Ferro, BSc (Hons), MBChB, FRCP, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Birmingham NHS Foundation Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Chronic kidney disease patients aged 18 to 80 years
- Chronic kidney disease stage 3 (defined as a glomerular filtration rate of 30-60
ml/min/1.73m2)
- Office blood pressure controlled to less than 140/90 mmHg for 12 months before entry
into the study
- Total cholesterol less than 5.5 mmol/l
Exclusion Criteria:
- Existing or previous treatment within 1 year with a phosphate binder or vitamin D
analogue
- Uncontrolled hyperphosphataemia (serum phosphate >1.8 mmol/l)
- Uncontrolled secondary hyperparathyroidism (PTH >80 pg/ml)
- Diabetes mellitus
- Pregnancy
- Moderate-severe cardiac valvular disease
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiovascular Diseases
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Kidney Failure, Chronic
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Intervention(s)
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Drug: Placebo
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Drug: Sevelamer carbonate
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Primary Outcome(s)
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Change in left ventricular mass
[Time Frame: 36 weeks]
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Secondary Outcome(s)
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Aortic compliance as measured by cardiac magnetic resonance imaging
[Time Frame: 36 weeks]
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Arterial elastance as measured by echocardiography
[Time Frame: 36 weeks]
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Arterial stiffness as measured by pulse wave velocity and pulse wave analysis
[Time Frame: 36 weeks]
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Bone density on dual-energy x-ray absorptiometry scanning
[Time Frame: 36 weeks]
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Left ventricular systolic and diastolic elastance measured by echocardiography
[Time Frame: 36 weeks]
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Secondary ID(s)
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2008-003727-23
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RRK3563
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SVCARB01508IST
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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