Ofatumumab in Children With Drug Resistant Idiopathic Nephrotic Syndrome
Status:
Terminated
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Double-blind, two-parallel-arm, placebo-controlled randomized clinical trial testing the
superiority of Ofatumumab versus placebo in the treatment of children with DR-INS.
Participants will be stratified according to eGFR at enrollment.
Eligible participants will enter a 3-months run-in period, during which instructions on urine
collection and dipstick readings will be carefully reviewed, compliance assessed and any
immunosuppressive therapies withdrawn according to the following schemes:
- prednisone will be tapered off by 0.3 mg/kg per week until complete withdrawal;
- calcineurin inhibitors and mofetile mycophenolate will be decreased by 50% and withdrawn
after 2 additional weeks In order to minimize the risk of complications of uncontrolled
INS a treatment with ACE-inhibitor at 6 mg/m2 will be maintained or started in all
patients.
After run-in period, children will be randomized to the intervention arm (Ofatumumab) or
comparator arm (placebo). Randomization will be stratified by eGFR at randomization: ≥90 and
<90 ml/min/1.73 m2.
All patients will be followed up to 12 months and they will leave the study at time of
relapse.
Relapse will be defined as uPCR ≥2000 mg/g (≥200 mg/mmol) or ≥ 3+ protein on urine dipstick
for 3 consecutive days.