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
Scientific
Charité - University Medicine Berlin
Department of Pediatric Nephrology
Berlin
13353
Germany
Study information
| Study design | Randomized controlled, cross-over, double-blind, multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sevelamer |
| Primary outcome measure | Decrease in serum cholesterol |
| Secondary outcome measures | 1. Decrease in other lipids 2. Markers of oxidative stress 3. Proteinuria |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité - University Medicine Berlin
Berlin
13353
Germany
13353
Germany
Sponsor information
Genzyme Europe
Industry
Industry
310 Cambridge Science Park
Cambridge
CB4 OWG
United Kingdom
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
