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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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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2383 |
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Date of registration:
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23/06/2010 |
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Primary sponsor: |
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Public title:
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Effect van fosfaat verlaging op FGF23 en bloedvaten.
Effect of phosphate reduction on FGF23 and bloodvessel function.
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Scientific title:
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Pilot study to investigate whether oral phosphorus binders can reduce FGF23 levels and can influence vascular function as measured by pulse wave velocity in patiens with chronic kidney disease stage 3 (eGFR 30-60 ml/min/1,73 m2). -
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Date of first enrolment:
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23/6/2010 |
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Target sample size:
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20 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2383 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: [default]; Control: [default]; Group: Parallel; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Annet
Bouma-de Krijger |
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Address:
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De Boelelaan 1117
1081 HV
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4442673 |
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Email:
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a.Bouma@vumc.nl |
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Affiliation:
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Name:
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P.M.
Wee, ter |
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Address:
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De Boelelaan 1117
1081 HV
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4442673 |
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Email:
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pmterwee@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with eGFR 30-60 ml/min/1,73 m2;
2. Serum phosphorus level <1,49 mmol/L and >1,0 mmol/L;
3. Age >18 year;
4. Informed consent.
Exclusion criteria: 1. Known allergy or intolerance for sevelamer-containing drugs;
2. Patients with heart failure;
3. Use of phosphate binder therapy;
4. Patients dependent on tube-feeding or those with malabsorption syndrome;
5. Rapidly deteriorating renal function;
6. Pregnant woman.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Chronic renal failure, Sevelamer-carbonate
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Intervention(s)
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Patients will be treated with sevelamer-carbonate (Renvela®) 2,4 g before breakfast and diner for 8 weeks. Patients remain on their usual diet.
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Primary Outcome(s)
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Serum FGF23 and phosphaturia before and after 8 weeks of treatment with sevelamer-carbonate.
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Secondary Outcome(s)
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Pulse Wave Velocity measured before and after the treatment with Sevelamer.
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Secondary ID(s)
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NL31055.029.09
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Source(s) of Monetary Support
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Genzyme Corporation, VU University Medical Center
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