A Phase 2 interventional study of Ofatumumab and Rituximab in Nephrotic Syndrome, sponsored by Istituto Giannina Gaslini. Completed at 1 site in Italy. Open to participants aged 2 Years to 24 Years. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Istituto Giannina Gaslini · Phase 2, Interventional, and Treatment
Open-label, two-parallel-arm, controlled randomized clinical trial testing the superiority of Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease remission in SD-INS.
Eligible participants will enter a 1-month run-in period, during which instruction on urine collection and dipstick readings will be carefully reviewed, compliance assessed, and therapy with RAS inhibitors withdrawn and, in hypertensive children replaced by other anti-hypertensive drug.
After run-in period, children will be randomized to either the intervention arm (Ofatumumab) or the comparator arm (Rituximab).
After infusion of intervention or comparator, steroids will be maintained at initial dose for 30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.
One week after the steroid withdrawal calcineurin inhibitors will be decreased by 50% and withdrawn within 2 additional weeks.
All patients will be followed for up to 24 months. In case of relapses during the study (see outcome section for definition) patients will be treated with 60 mg/m2of prednisone p.o. in order to achieve remission. At remission, patients will be treated with another infusion of either Oftumumab or Rituximab, according to the initial randomization.
After infusion of intervention or comparator, steroids will be maintained at initial dose for 30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.
One week after the steroid withdrawal calcineurin-inhibitors will be decreased by 50% and withdrawn within 2 additional weeks. This strategy will be repeated to treat full relapses during the study.
192 studies on the registry are indexed under Nephrotic Syndrome; 63 are open to participants now.
This study's enrollment of 140 is above the median of 60 across 123 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →Istituto Giannina Gaslini is the lead sponsor of 32 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be eligible for inclusion into this study, participants will have to fulfill the following criteria:
Exclusion Criteria:
Children will be excluded if any of the following criteria apply:
* Drug Name: Ofatumumab * Why: Anti-body/antigen interaction results in cell apoptosis and reduced CD20 positive cell related activities * Procedures: methylprednisolone 2 mg/kg infused in 30' IV diluted in 100 ml of normal saline (NaCl 0,9%); oral paracetamol 15 mg/kg ; cetirizine 0,4 mg/kg IV infused slowly in 5 ml of normal saline (NaCl 0,9%) prior to Ofatumumab infusion to reduce common reactions * How: Ofatumumab IV: 1500 mg/1.73m2 at 12 ml/hour in the first 30'. Thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 200 ml/hour. * When and how much: once; diluted in 1000 ml of normal saline.
Drug: Ofatumumab
* Drug Name: Rituximab (RTX) * Why: Anti-body/antigen interaction results in cell apoptosis and reduced CD20 positive cell related activities * Procedures: the same as for Ofatumumab Arm * How: Rituximab IV: 375 mg/m2; for dosage between 100 and 250 mg RTX will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg RTX will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg RTX will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h. * When and how much: once; diluted in 100/250/500 ml of normal saline for dosage respectively between 100-250 mg, 260-500 mg, 510-1000 mg.
Drug: Rituximab
1500 mg/1.73m2, administered once diluted in 1000 ml of normal saline
Also known as: Arzerra
375 mg/m2, administered once diluted in 100/250/500 ml of normal saline for dosage respectively between 100-250 mg, 260-500 mg, 510-1000 mg.
Also known as: Mabthera
Risk of relapse
The primary endpoints will be risk of relapse at 12 months without steroid or calcineurin-inhibitors. Relapse is defined by uPCR ≥2000 mg/g (≥ 200 mg/mmol) or \> 3+ protein on urine dipstick for 3 consecutive days (KDIGO Clinical Practice Guideline for Glomerulonephritis, Kidney International Supplement, 2012 2, 163-171).
Time frame: 12 months
Amount of steroids required to maintain complete disease remission
Complete remission is defined by uPCR \<200 mg/g (\<20 mg/mmol) or o1+ of protein on urine dipstick for 3 consecutive days (KDIGO Clinical Practice Guideline for Glomerulonephritis, Kidney International Supplement, 2012 2, 163-171).
Time frame: 6 and 24 months after Ofatumumab or Rituximab pulse
Adverse events
Measurement of frequency and severity of adverse events due to drug infusion
Time frame: At 1, 3, 6, 9 ,12, 15, 18, 21 and 24 months after drug infusion, during protocol visits.
Abnormal laboratory values
Record of abnormal values in biochemical tests and hematology assessments due to drug infusion
Time frame: At 1, 3, 6, 9 ,12, 15, 18, 21 and 24 months after drug infusion, during protocol visits.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Istituto Giannina Gaslini