Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EK 1656/Si 238
Study information
Scientific title
Acronym
Study hypothesis
Sevelamer, but not placebo, lowers hypercholesterolemia in children with persisting proteinuria or nephrotic syndrome
Ethics approval
Ethics Committee of Charité - University Medicine Berlin on 05/09/2002, reference number 1778/Si 254
Study design
Randomized controlled, cross-over, double-blind, multicenter trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Glomerular diseases with proteinuria
Intervention
Sevelamer versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Sevelamer
Primary outcome measures
Decrease in serum cholesterol
Secondary outcome measures
1. Decrease in other lipids
2. Markers of oxidative stress
3. Proteinuria
Overall trial start date
01/01/2005
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged 2-18 years, with persisting proteinuria and hypercholesterolemia.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Chronic renal insufficiency (glomerular filtration rate [GFR] <40 ml/min)
2. Genetic forms of hyperlipidemia
3. Hyperlipidemia due to other causes
Recruitment start date
01/01/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Charité - University Medicine Berlin
Berlin
13353
Germany
Funders
Funder type
Industry
Funder name
Genzyme Europe
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary