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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN06912061
Enrollment
20
Registered
2006-05-26
Start date
2005-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerular diseases with proteinuria Nutritional, Metabolic, Endocrine Proteinuria, hyperlipidemia

Interventions

Sevelamer versus placebo

Sponsors

Genzyme Europe
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged 2-18 years, with persisting proteinuria and hypercholesterolemia.

Exclusion criteria

Exclusion criteria: 1. Chronic renal insufficiency (glomerular filtration rate [GFR] <40 ml/min) 2. Genetic forms of hyperlipidemia 3. Hyperlipidemia due to other causes

Design outcomes

Primary

MeasureTime frame
Decrease in serum cholesterol

Secondary

MeasureTime frame
1. Decrease in other lipids 2. Markers of oxidative stress 3. Proteinuria

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026