| DEC-NET Serial number FR357 |
| |
| Published online | 07/03/2005 15.22.00 |
| Last updated | 27/11/2006 10.19.18 |
| |
| Other protocol ID number | |
| Current trial status | Terminated (withdrawn) |
Major Disease
(ICD9 class) | Nephrotic syndrome |
| Experimental drug |
furosemide
Treatment regimen (dosage and duration)
2 mg/kg/day.
Two presentations will be used according to the age:
-liquid solution (10 mg/ml)
-tablets of 20 or 40 mg
|
amiloride
Treatment regimen (dosage and duration)
oral administration adapted to weight without exceeding 20 mg/day |
| Gender | Both |
| Age (range) | 2 - 17 years |
Eligibility criteria |
| Inclusion criteria |
| All the following criteria must be present:
-Children already hospitalized for a nephrotic syndrome
-Aged 2 to 17 years
-Nephrotic syndrome defined by a proteinuria > 50 mg/kg/jour and albuminemia < 30g/l, corticoresistant due to a glomerular disease .
-Oedema and clinical ascite with overweight estimated to be at least than 10% of the basic body weight.
-Oedemea syndrome responsible for local complication or invalidating discomfort.
-Assent signed by the 2 parents and the child |
| Exclusion criteria |
| One of the following criteria is sufficientfor exclusion:
-Clinical signs of hypovolemia : tachycardia,arterial hypotension, abdominal painful syndrome
-Biological signs of hypovolemia (Hematocrit > 45%)
-Kaliemia > 5 mmol/l or 3.5 mmol/l
-Contraindication with the one of the two diuretics : allergy to sulphamide or amiloride, hepatic encephalopathy, urinary obstruction (ultrasonographic dilation of the renal cavities).
-Others diuretics administered during trial period and less than 4 days before inclusion |
Trial design/methodology |
| Phase | 3 |
| Kind of study | Efficacy
|
| Design | Randomised
|
| Purpose of study |
| Primary objective : To prove that the qssociation amiloride + furosemide induces a natriuria more important than furosemide alone in patients with nephrotic syndrome
Secondary objectives :
1/To demonstrate that the increased natriuria results in weight loss (oedema) more important in the group receiving furosemide + amiloride than in the groupreceiving furosemide alone
2/To show that amiloride reduces the resistance to furosemide in patients in nephrotic patients. |
|
|
|
|
| Summary of study design, objectives, and ongoing research findings |
| it is an open randomized comparative study with two study periods :
1/Control period (n=20)of 48h, without diuretic treatment but with a the control diet (0.5 mmol/kg/day sodium).
- Randomized treatmet period of 96 hours:
Group A (n=10): furosemide
Groupe B (n=10): furosemide + amiloride
This study will evaluate the capacity of amiloride to induce a sodium natriuresis and to improve of oedema resorption by reducing the resistance phenomena due to furosemide. |
