treatment of cortico-dependent nephrotic syndrome in children MedDRA version: 6.1 Level: HLT Classification code 10018365
Conditions
Interventions
Pharmaceutical Form: Solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Chldren with steroid-dependent nephrotic s. lasting from more than one year 2 In remission without proteinuria one month before the enrollement . 3 Age old, between 3-18 years Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 steroid-resistent nephrotic s. 2 concomitant virus infections 3 reported membrane defects in erythrocytes and/or hemoglobin anomalies. 4 relaps of nephrotic s. within one month from the start of then study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: First objective to evaluate both efficacy and safety of intra-erythrocytes dexamethasone in mantening stable remission of cortico-dependent nephrotic syndrome in children;Secondary Objective: Second objective To achieve a partial remission in the same cohort of patients and reduce the therapeutic load of steroid. The long term aim is to decrease the steroid side effects.;Primary end point(s): First objective to evaluate both efficacy and safety of intra-erythrocytes dexamethasone in mantening stable remission of cortico-dependent nephrotic syndrome in children | — |
Countries
Italy
Outcome results
None listed