NCT00638482

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
Last Updated

March 19, 2008

Status Verified

July 1, 2003

Enrollment Period

2.4 years

First QC Date

March 12, 2008

Last Update Submit

March 17, 2008

Conditions

Dent's DiseaseNephrolithiasis

Keywords

Dent's diseaseNephrolithiasisclinical trialthiazides

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (2)

  • clinical events (cramps, symptomatic dehydration, acute weight loss)

    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)

    at least two times overall the study, at J15 and at the end of each period.

Study Arms (1)

1

EXPERIMENTAL

Hydrochlorothiazide

Drug: Hydrochlorothiazide

Interventions

HydrochlorothiazideDRUG

Hydrochlorothiazide

1

Eligibility Criteria

Age3 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigation clinique HOPITAL GEORGE POMPIDOU

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 18976849DERIVED

MeSH Terms

Conditions

Dent DiseaseNephrolithiasis

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrolithiasis

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Anne BLANCHARD, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

July 1, 2003

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

March 19, 2008

Record last verified: 2003-07

Locations

FR(1)