Nephrotic syndrome relapse in children MedDRA version: 21.1 Level: LLT Classification code 10029172 Term: Nephrotic syndrome with unspecified pathological lesion in kidney System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1 Level: PT Classification code 10029164 Term: Nephrotic syndrome System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1 Level: LLT Classification code 10029168 Term: Nephrotic syndrome with lesion of minimal change glomer
Conditions
Interventions
Trade Name: Prednisolon Mylan 20 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Radboudumc, Amalia Children’s Hospital, Department of Pediatrics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age over 1 and less than 18 years; • Steroid sensitive nephrotic syndrome; • The last prednisolone use (at a dose over 10 mg/m2 on alternate days) for the treatment of a previous episode was at least 4 weeks ago; • Signed informed consent from the parent or legal assent and/or the patient, depending on the age of the patient. Are the trial subjects under 18? yes Number of subjects for this age range: 144 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: • Steroid resistant nephrotic syndrome; • Daily prednisolone maintenance therapy at any dose; • Alternate day prednisolone maintenance therapy at a dose over 4 mg/m2; • Documented or suspected significant non-compliance; • Pregnancy; • Stimulant drug use; • Comorbidity; o Kidney transplant recipient; o Any disease that requires the variation in oral prednisolone to be at the discretion of the treating physician(s); • Concomitant use of drugs that induce CYP 3A4: carbamazepine, phenobarbital, phenytoin and/or rifampicin; • Concomitant use of drugs that inhibit CYP 3A4: ketaconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics (erythromycin), diltiazem, verapamil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To study the effectiveness of a reduced steroid schedule for the treatment of a relapse in children with steroid sensitive nephrotic syndrome. ;Secondary Objective: Secondary Objective(s): •To study the influence of maintenance immunosuppressive therapy on the effectiveness of a reduced steroid schedule for the treatment of a relapse in children with steroid sensitive nephrotic syndrome; •To study the course of relapses in children with nephrotic syndrome under the standard treatment regimen; •To study the influence of maintenance immunosuppressive therapy on the course of relapses in children with nephrotic syndrome under the standard treatment regimen. ;Primary end point(s): Time to first relapse after study randomization (assessed 24 months);Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of relapses after study randomization at 12 or 24 months • Development of frequent relapsing nephrotic syndrome according to KDIGO criteria (four or more relapses in any 12-month period) • Development of steroid dependent nephrotic syndrome according to KDIGO criteria (two consecutive relapses during corticosteroid therapy, or within 14 days of ceasing therapy) • Cumulative dosage of prednisolone during study period (at 12 and 24 months) ;Timepoint(s) of evaluation of this end point: 12 and 24 months | — |
Countries
Belgium, Germany, Netherlands
Contacts
Public ContactPediatric Drug Research Centre
Radboudumc, Amalia Children’s Hospital
Outcome results
None listed