Prospective study to improve therapy with prednisone for relapse of idiopathic nephrotic syndrome in childre

Conditions: At least one relapse of INS in the last year, normal renal function (creatinine clearance> 90 mL/min/1.73 m2)
INS in remission at the time of enrollment (if the patient has recently had a relapse can be enrolled only after finishing therapy with PDN or be returned to its usual maintenance dose)
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2012-004326-16-IT

Lead Sponsor: OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Aged between 3 and 17 years at enrollment • At least one recurrence of INS in the last year • normal renal function (creatinine clearance> 90 mL/min/1.73 m2) • INS in remission at the time of enrollment (if the patient has recently had a relapse can be enrolled only after finishing therapy with PDN or be returned to its usual maintenance dose)
Are the trial subjects under 18? yes
Number of subjects for this age range: 126
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

• Patients with comorbidities not related to the INS • Patients with steroid-resistant INS • Patients who achieved remission in more than 21 days during the last relapse (pcs at risk of secondary steroid resistance) • Patients who have fallen in the previous year while receiving therapy with PDN higher dose of 30 mg/m2 on alternate days (severe steroid dependency, which may require the addition of an immunosuppressant drug) • Patients who are on maintenance therapy with PDN at the higher dose of 15 mg/m2 every other day • Patients receiving other immunosuppressive drugs (should have been suspended for at least 3 months) • Patients treated with antihypertensive drugs