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

This study has been terminated.

(terminated)

Sponsor:

Information provided by:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00638482

First received: March 12, 2008

Last updated: March 17, 2008

Last verified: July 2003

History of Changes

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 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pharmacodynamic Evaluation of the ANTICALCIURIC Effect of Hydrochlorothiazide in Dent's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Dent disease

Drug Information available for: Hydrochlorothiazide

Genetic and Rare Diseases Information Center resources: Dent Disease

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, ]

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. ]
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. ]


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
Experimental: 1 Hydrochlorothiazide	Drug: Hydrochlorothiazide Hydrochlorothiazide

Show Detailed Description

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received:	March 12, 2008
Last Updated:	March 17, 2008

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

ClinicalTrials.gov processed this record on May 25, 2017

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