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:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT01268033
Eligibility Criteria:
Inclusion Criteria:
* Male or Female patients over 2 and under 18 years, with an idiopathic nephrotic syndrome (NS)
* Steroid Sensitive Nephrotic Syndrome (according to the French pediatric protocol).
NEPHRUTIX
* Calcineurin inhibitor Dependent NS or NS for which anticalcineurin treatment has not been effective. Others immunosuppressive treatments (MMF) must have failed to control the disease activity.
* Effective contraception for girls of childbearing age.
* The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtained prior to the initiation of any study procedure
Exclusion Criteria:
* Terminal renal failure requiring dialysis/transplantation
* Transcutaneous oxygen stauration \< 97%
* Clinical or Radiological brochopulmonar or pleural abnormality
* Asymptomatic carrier of Hepatitis B virus our history of Hepatitis B
* Contraindication to Rituximab (RTX)
* Parents/patient refusing to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT01268033
Study Brief:
Protocol Section:
NCT01268033