Nephrolithiasis Clinical Trial
— DESYOfficial title:
Pharmacodynamic Evaluation of the ANTICALCIURIC Effect of Hydrochlorothiazide in Dent's Disease
Verified date | July 2003 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | December 2005 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 3 Years to 18 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Centre d'investigation clinique HOPITAL GEORGE POMPIDOU | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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, | Yes | |
Secondary | clinical events (cramps, symptomatic dehydration, acute weight loss) | at least two times overall the study, at J15 and at the end of each period. | Yes | |
Secondary | Biological : acute renal failure (estimated GFR), hypokalemia, hyperkalemia, hyponatremia, biological signs of extra cellular dehydration (protides, hematocrit, plasma active renin, plasma aldosterone) | at least two times overall the study, at J15 and at the end of each period. | Yes |
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