Status:
NOT_YET_RECRUITING
Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Idiopathic Nephrotic Syndrome
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief 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-ter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT07151456
Start Date
January 1 2026
End Date
December 1 2029
Last Update
September 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000