Trial record 4 of 7 for:
"Dent disease"
Dose-Dependent Effect of Thiazide in Dent's Disease Hypercalciuria (DESY)
This study has been terminated.
(terminated)
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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 Endpoint Classification: Safety/Efficacy Study 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
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 |
|---|---|
|
Experimental: 1
Hydrochlorothiazide
|
Drug: Hydrochlorothiazide
Hydrochlorothiazide
Other Name: 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
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
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 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 |
| Study First Received: | March 12, 2008 |
| Last Updated: | March 17, 2008 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Dent's disease Nephrolithiasis clinical trial thiazides |
Additional relevant MeSH terms:
|
Dent Disease Nephrolithiasis Genetic Diseases, Inborn Genetic Diseases, X-Linked Kidney Diseases Metabolic Diseases Metabolism, Inborn Errors Renal Tubular Transport, Inborn Errors Urolithiasis Urologic Diseases Hydrochlorothiazide |
Antihypertensive Agents Cardiovascular Agents Diuretics Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Natriuretic Agents Pharmacologic Actions Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015