Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study (NCT07151456) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study
China224 participantsStarted 2026-01
Plain-language summary
This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Relapse
Timeframe: through study completion, an average of 2 years
Trial details
NCT IDNCT07151456
SponsorFirst Affiliated Hospital of Wenzhou Medical University