Dettagli per singolo studio

DEC-NET Serial number FR323

Published online	07/10/2004 15.16.00
Last updated	08/09/2005 10.45.26

Other protocol ID number	P011114
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Major Disease (ICD9 class)	Nephritis and nephropathy, not specified as acute
Experimental drug
Hydrochlorothiazide Treatment regimen (dosage and duration) 6.25-25 mg/day oral administration. Period A(30 days): amiloride 5mg/d Period B(60 days):Esidrex 6.25/d + amiloride 5mg/d Period C(60 days):Esidrex 12.5mg/d + amiloride 5mg/d period D (60 days): Esidrex 25mg/d + amiloride 5mg/d Period E: Control (30 days)
Amiloride Chlorhydrate anhydre Treatment regimen (dosage and duration) 5 mg/day oral admistration. Period A(30 days): amiloride alone Period B(60 days):amiloride + Esidrex 6.25 mg/d Period C(60 days):amiloride + Esidrex 12.5mg/d Period D (60 days): amiloride + Esidrex 25mg/d Period E: Control (30 days)
Gender	Both
Age (range)	4-40 years
Eligibility criteria
Inclusion criteria
- Male patients with genetically confirmed Dent syndrome or female carrying the mutation. - Presenting a symptomatic hypercalciuria.
Exclusion criteria
- Hyperkaliemia < 3.0 mM - Hyponatremia - Recently stopped (less that 15 days) or ongoing diuretic treatment - Advanced renal failure - Women of childbearing age, without effective contraception. - Hypercalciuria of another aethiology
Trial design/methodology
Phase	2
Kind of study	Efficacy Safety
Design
Purpose of study
To study the tolerance and efficacy of increasing the doses of the thiazidic diuretic ESIDREX, associated with a potassium sparing diuretic MODAMIDE at a fixed dose




Summary of study design, objectives, and ongoing research findings
The aim of the present study is to reduce the risks associanted with the use of thiazidic duiretics in Dent syndrome by: 1/ detecting sodium lost 2/ reducing the doses of diuretics usually administered by a progessive increase of the daily dose 3/ preventing hypokaliemia by the concomittant administration of a potassium sparing diuretic