Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/03/2006
Date assigned
26/05/2006
Last edited
26/05/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Uwe Querfeld

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Genzyme Europe

Sponsor details

310 Cambridge Science Park
Cambridge
CB4 OWG
United Kingdom

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes