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

ISRCTN ISRCTN06912061
DOI https://doi.org/10.1186/ISRCTN06912061
Secondary identifying numbers EK 1656/Si 238
Submission date
23/03/2006
Registration date
26/05/2006
Last edited
26/05/2006
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
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

Contact information

Prof Uwe Querfeld
Scientific

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

Study information

Study designRandomized controlled, cross-over, double-blind, multicenter trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesSevelamer, 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) studiedGlomerular diseases with proteinuria
InterventionSevelamer versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Sevelamer
Primary outcome measureDecrease in serum cholesterol
Secondary outcome measures1. Decrease in other lipids
2. Markers of oxidative stress
3. Proteinuria
Overall study start date01/01/2005
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteriaChildren aged 2-18 years, with persisting proteinuria and hypercholesterolemia.
Key exclusion criteria1. Chronic renal insufficiency (glomerular filtration rate [GFR] <40 ml/min)
2. Genetic forms of hyperlipidemia
3. Hyperlipidemia due to other causes
Date of first enrolment01/01/2005
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Charité - University Medicine Berlin
Berlin
13353
Germany

Sponsor information

Genzyme Europe
Industry

310 Cambridge Science Park
Cambridge
CB4 OWG
United Kingdom

ROR logo "ROR" https://ror.org/02n6c9837

Funders

Funder type

Industry

Genzyme Europe

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan