Dose-Dependent Effect of Thiazide in Dent's Disease Hypercalciuria (DESY)
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ClinicalTrials.gov Identifier: NCT00638482 |
Recruitment Status
:
Terminated
(terminated)
First Posted
: March 19, 2008
Last Update Posted
: March 19, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dent's Disease Nephrolithiasis | Drug: Hydrochlorothiazide | Phase 2 Phase 3 |

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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Hydrochlorothiazide
|
Drug: Hydrochlorothiazide
Hydrochlorothiazide
|
- 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, ]
- 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. ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638482
France | |
Centre d'investigation clinique HOPITAL GEORGE POMPIDOU | |
Paris, France, 75015 |
Principal Investigator: | Anne BLANCHARD, MD PhD | Assistance Publique - Hôpitaux de Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |