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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Dent's Disease; Nephrolithiasis	Drug: Hydrochlorothiazide	Phase 2; Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Pharmacodynamic Evaluation of the ANTICALCIURIC Effect of Hydrochlorothiazide in Dent's Disease
Study Start Date :	July 2003
Actual Primary Completion Date :	December 2005
Actual Study Completion Date :	December 2005

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; Hydrochlorothiazide	Drug: Hydrochlorothiazide; Hydrochlorothiazide

Outcome Measures

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Primary Outcome Measures :

1. 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 [ Time Frame: 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, ]

Secondary Outcome Measures :

1. clinical events (cramps, symptomatic dehydration, acute weight loss) [ Time Frame: at least two times overall the study, at J15 and at the end of each period. ]
2. Biological : acute renal failure (estimated GFR), hypokalemia, hyperkalemia, hyponatremia, biological signs of extra cellular dehydration (protides, hematocrit, plasma active renin, plasma aldosterone) [ Time Frame: at least two times overall the study, at J15 and at the end of each period. ]

Eligibility Criteria

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Ages Eligible for Study:	3 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

France
Centre d'investigation clinique HOPITAL GEORGE POMPIDOU
Paris, France, 75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Anne BLANCHARD, MD PhD	Assistance Publique - Hôpitaux de Paris

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Blanchard A, Vargas-Poussou R, Peyrard S, Mogenet A, Baudouin V, Boudailliez B, Charbit M, Deschesnes G, Ezzhair N, Loirat C, Macher MA, Niaudet P, Azizi M. Effect of hydrochlorothiazide on urinary calcium excretion in dent disease: an uncontrolled trial. Am J Kidney Dis. 2008 Dec;52(6):1084-95. doi: 10.1053/j.ajkd.2008.08.021. Epub 2008 Oct 30.

Responsible Party:	Saliha.DJANE, Department Clinical Research
ClinicalTrials.gov Identifier:	NCT00638482 History of Changes
Other Study ID Numbers:	P011114; AOM 1093
First Posted:	March 19, 2008
Last Update Posted:	March 19, 2008
Last Verified:	July 2003

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Dent's disease; Nephrolithiasis; clinical trial; thiazides

Additional relevant MeSH terms:

Dent Disease; Nephrolithiasis; Kidney Calculi; Kidney Diseases; Urologic Diseases; Urolithiasis; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Renal Tubular Transport, Inborn Errors; Genetic Diseases, X-Linked	Genetic Diseases, Inborn; Metabolism, Inborn Errors; Metabolic Diseases; Hydrochlorothiazide; Antihypertensive Agents; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Chloride Symporter Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action