Prospective, multicenter, double-blind, randomized, cross-over study to evaluate efficacy and safety of sevelamer in the treatment of dyslipidemia in children with persisting proteinuria

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Uwe Querfeld
Scientific

Charité - University Medicine Berlin
Department of Pediatric Nephrology
Berlin
13353
Germany

Primary study design	Interventional
Study design	Randomized controlled, cross-over, double-blind, multicenter trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Sevelamer, but not placebo, lowers hypercholesterolemia in children with persisting proteinuria or nephrotic syndrome
Ethics approval(s)	Ethics Committee of Charité - University Medicine Berlin on 05/09/2002, reference number 1778/Si 254
Health condition(s) or problem(s) studied	Glomerular diseases with proteinuria
Intervention	Sevelamer versus placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sevelamer
Primary outcome measure(s)	Decrease in serum cholesterol
Key secondary outcome measure(s)	1. Decrease in other lipids 2. Markers of oxidative stress 3. Proteinuria
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	Children aged 2-18 years, with persisting proteinuria and hypercholesterolemia.
Key exclusion criteria	1. Chronic renal insufficiency (glomerular filtration rate [GFR] <40 ml/min) 2. Genetic forms of hyperlipidemia 3. Hyperlipidemia due to other causes
Date of first enrolment	01/01/2005
Date of final enrolment	31/12/2007

Charité - University Medicine Berlin

Berlin
13353
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan