TerminatedPhase 2/3

Dose-Dependent Effect of Thiazide in Dent's Disease Hypercalciuria

Stopped: terminated

France10 participantsStarted 2003-07

Plain-language summary

Intrarenal calcifications (nephrocalcinosis) is present in Dent's disease and likely contribute to progression toward renal failure. In order to prevent this complication it is usually proposed to treat affected patients during childhood with high doses of thiazides.

Who can participate

Age range3 Years – 18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children \> 3 yrs old who met at least three standard criteria for Dent's disease including hypercalciuria, low molecular weight proteinuria and one of the following disorders: nephrocalcinosis, nephrolithiasis, renal failure, aminoaciduria, glucosuria, renal phosphate wasting, or familial history of Dent's disease. * Dent's Disease confirmed by direct sequencing of the CLCN5 gene according to Lloyd et al. Exclusion Criteria: * Patients presenting hyponatremia (\< 135 mM), hypokalaemia (\< 3.3 mM), severe fanconi syndrome, or chronic renal failure (GFR estimated with the Schwartz formula \< 30 mL.min-1.1.73m-2) were excluded from the study. * Overt renal loss of sodium * Inability to adapt to severe sodium restriction

What they're measuring

to investigate the dose-dependent benefit/risk ratio of low (6.25 mg/day), intermediate (12.5 mg/day) and high (25 mg/day) doses of hydrochlorothiazide

Timeframe: at the end of the baseline initial and final washout periods (one month each) and at the end of each two-months duration treatment period,

Trial details

NCT IDNCT00638482

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-12

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