At least one relapse of INS in the last year, normal renal function (creatinine clearance> 90 mL/min/1.73 m2)
Conditions
Interventions
Pharmaceutical Form: Tablet
CAS Number: 53-03-2
Pharmaceutical Form: Tablet
CAS Number: 53-03-2
Sponsors
OSPEDALE PEDIATRICO BAMBINO GESU' DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to test the optimal modalities of PDN treatment for relapses of INS and to show the superiority of one of the two proposed PDN protocols.;Secondary Objective: The secondary aims of the study are: - to investigate the safety of the two PDN treatment schedules; to evaluate the prognostic value of transient, self-remitting proteinuria (1+ to 3+) during follow-up in predicting incipient relapses of INS; - to evaluate the prognostic value of “trace” proteinuria (as opposed to “0” proteinuria) in predicting incipient relapses of INS; - to evaluate the prognostic value of the time to remission (days) after re-induction with PDN in predicting the rapidity of subsequent relapses. These secondary aims will allow elaboration of future trials aimed at reducing the total burden of steroid therapy by treating preventively with shorter courses of PDN patients that are at high risk of imminent relapse.;Primary end point(s): The primary outcome of the study was the proportion of patients in remission at 6 months after treatment. Is also evaluated the relative toxicity of the PDN in the two protocols.;Timepoint(s) of evaluation of this end point: six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include: - Changes in blood pressure - Changes in body mass index and weight - Frequency of infections and other adverse events. Serious adverse events will be recorded from the time of obtaining informed consent throughout the study period. Subjects who will discontinue the study prematurely will continue to be monitored for safety where possible (although they will probably receive PDN as their standard treatment for INS, or will be switched to more intensive immunosuppressive medications, which are more likely to be responsible for new adverse events). - Frequency of borderline dipsticks after remission (`trace`) - Frequency of self-remitting proteinuria after remission.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactNefrologia e Dialisi
Ospedale Pediatrico Bambino Gesù
Outcome results
None listed