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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT07151456
Eligibility Criteria:
Inclusion Criteria:
* Urine protein: creatinine ratio ≥3000mg/g (300mg/mmol)
* Serum/plasma albumin level \< 30g/L
* Age ≥ 16 years at the time of diagnosis
* No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice)
* No evidence of underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome
* Informed consent
* SSNS defined as Complete remission within 4 weeks of prednisone or prednisolone at standard dose
Exclusion Criteria:
* Secondary nephrotic syndrome
* Contradictions for glucocorticoids
* SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose
* anti-PLA2R positive
* Adults with histological changes other than minimal lesion or focal segmental glomerular sclerosis (FSGS) glomerulonephritis where renal biopsy has been undertaken
* Adults with a prior history of poor compliance with medical therapy Known allergy to glucocorticoid therapy
* Other situations where the researcher deems it inappropriate to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT07151456
Study Brief:
Protocol Section:
NCT07151456