This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: March 12, 2008
Last updated: March 17, 2008
Last verified: July 2003
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: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamic Evaluation of the ANTICALCIURIC Effect of Hydrochlorothiazide in Dent's Disease

Resource links provided by NLM:

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
Drug: Hydrochlorothiazide

  Show Detailed Description


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
  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 identifier: NCT00638482

Centre d'investigation clinique HOPITAL GEORGE POMPIDOU
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Anne BLANCHARD, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Saliha.DJANE, Department Clinical Research 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
clinical trial

Additional relevant MeSH terms:
Kidney Calculi
Dent Disease
Kidney Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical
Renal Tubular Transport, Inborn Errors
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metabolic Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017