Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT05786768
Eligibility Criteria:
Inclusion Criteria:
* Age between 3 and 18 years
* Steroid dependant Nephrotic Syndrome defined as:
* 2 or more relapses during steroids or within 2 weeks following discontinuation.
* 2 or more relapses including one under steroid-sparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, levamisole) or within 6 months following treatment withdrawal
OR Frequent Relapsing Nephrotic Syndrome defined as:
* 2 or more relapses within 6 months following first remission
* 3 or more relapses within any 12-month period
* Last relapse within 3 months prior to inclusion
* In remission, defined as 3 consecutive urinary dipsticks without proteinuria, at the time of randomization
* Vaccination schedule in accordance with the current recommendations in France
* Informed consent from parents
Exclusion Criteria:
* Secondary cause of nephrotic syndrome (such as membranous nephropathy, IgA nephropathy, lupus nephritis)
* Primary or secondary steroid resistance nephrotic syndrome
* Prior treatment with Rituximab within 6 months
* Prior treatment with obinutuzumab at any time
* CD20+ B-cell count \< 2.5%
* Patient with neutrophils \< 1.5 G/L and/or platelets \< 75 G/L
* GFR \< 80 ml/min/1.73m2
* Weight \<16kg
* History of severe infection such as tuberculosis, hepatitis B, hepatitis C or HIV infection or LEMP
* History of malignancy- Uncontrolled infection (viral, bacterial and fungal)
* Vaccination with a live vaccine within 4 weeks prior to assignment/randomization
* Known hyperprolinemia
* Hypersensitivity to the active substance (OBI or RTX) or to proteins of murine origin, or to any of the other excipients
* Pregnancy or breastfeeding or ability to become pregnant and refusal to use effective contraception during the 18 months following the study treatment (only 1 infusion of obinutuzumab/Rituximab at the beginning of the study)
* Patient without medical insurance coverage (beneficiary or legal)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT05786768
Study Brief:
Protocol Section:
NCT05786768