Nephrotic syndrome Nefrotisch syndroom
Conditions
Interventions
Treatment schedule
• Prednisone 60mg/m2 (max 60mg) daily in 1 dose until complete remission for 3 days (according to the KDIGO guideline)
• Randomization:
o Standard treatment: 4-6 weeks prednisone
Sponsors
Dr. Michiel F Schreuder, MD PhD
Pediatric Nephrologist
Radboudumc Amalia Children's Hospital
Department of Pediatric Nephrology, 804
P.O.Box 9101, 6500 HB Nijmegen
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: • Age over 1 and less than 18 years • Steroid sensitive nephrotic syndrome. This will include the following groups: o Subjects without maintenance immunosuppressive therapy; o Subjects with maintenance immunosuppressive therapy: • Long-term immunosuppressive therapies, including levamisole, ciclosporine, tacrolimus, MMF, mycophenolate sodium, prednisolone; • Subjects with prednisolone maintenance therapy may be included when administered every other day at a maximum of 4mg/m2 (10% of the study dose) • Subjects experience a relapse nephrotic syndrome, defined as Albustix positive proteinuria (3+ or greater) for three consecutive days or the presence of generalised oedema plus 3+ proteinuria; • Informed consent; • 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.
Exclusion criteria
Exclusion criteria: • Steroid resistant nephrotic syndrome; • Documented or suspected significant non-compliance. • Daily prednisolone maintenance therapy at any dose • Alternate day prednisolone maintenance therapy at a dose over 4 mg/m2 • 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 |
|---|---|
| Time to first relapse after study randomization (censored at 12 and 24 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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 prednisone during study period (at 12 and 24 months) | — |
Contacts
Public ContactMichiel F Schreuder
Radboudumc Amalia Children's Hospital - Department of Pediatric Nephrology, 804
Outcome results
None listed