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

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00638482

Purpose

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	Intervention	Phase
Dent's Disease Nephrolithiasis	Drug: Hydrochlorothiazide	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pharmacodynamic Evaluation of the ANTICALCIURIC Effect of Hydrochlorothiazide in Dent's Disease

Resource links provided by NLM:

MedlinePlus related topics: Kidney Stones

Drug Information available for: Hydrochlorothiazide

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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, ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	July 2003
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Hydrochlorothiazide	Drug: Hydrochlorothiazide Hydrochlorothiazide

Show Detailed Description

Eligibility

Ages Eligible for Study:	3 Years to 18 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638482

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

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Oct 30.

Responsible Party:	Department Clinical Research ( Saliha.DJANE )
Study ID Numbers:	P011114, AOM 1093
Study First Received:	March 12, 2008
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00638482 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Dent's disease
Nephrolithiasis
clinical trial
thiazides

Study placed in the following topic categories:

Urologic Diseases
Urolithiasis
Sodium Chloride Symporter Inhibitors
Diuretics
Hypercalciuria

Cardiovascular Agents
Kidney Diseases
Antihypertensive Agents
Hydrochlorothiazide
Nephrolithiasis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Urolithiasis
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Membrane Transport Modulators
Urologic Diseases
Natriuretic Agents
Therapeutic Uses
Kidney Diseases
Nephrolithiasis

ClinicalTrials.gov processed this record on September 10, 2009