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short-term gluCOCOrticoid in Adult STEROID-sensitive nephrotic syndrome: The COCO-ASTEROID Study

Short-term vs Conventional Glucocorticoid Therapy for the Treatment of the Initial Episode of Adult Patient with Steroid-sensitive Idiopathic Nephrotic Syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111892
Enrollment
Unknown
Registered
2025-11-07
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Initial Episode of Adult Patient with Steroid-sensitive Idiopathic Nephrotic Syndrome

Interventions

conventional course prednisolone arm:Conventional 24-week glucocorticoid regimen
short-term course prednisolone arm:short-term course (12 week) glucocorticoid regimen

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Urine protein: creatinine ratio >=3000mg/g (300mg/mmol), determined quantitatively on an early morning urine sample; 2. Serum/plasma albumin level = 16 years at the time of diagnosis; 4. 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); 5. No evidence of underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome; 6. Informed consent; 7. SSNS defined as Complete remission within 4 weeks of prednisone or prednisolone at standard dose.

Exclusion criteria

Exclusion criteria: 1. Secondary nephrotic syndrome; 2. Contradictions for glucocorticoids; 3. SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose; 4. anti-PLA2R positive; 5. Adults with histological changes other than minimal lesion or focal segmental glomerular sclerosis (FSGS) glomerulonephritis where renal biopsy has been undertaken; 6. Adults with a prior history of poor compliance with medical therapy; 7. Known allergy to glucocorticoid therapy; 8. Other situations where the researcher deems it inappropriate to participate in the study;

Design outcomes

Primary

MeasureTime frame
First recurrence time;

Secondary

MeasureTime frame
recurrence rate;Proportion of hormone dependent diseases;Proportion of second-line and third line immunosuppressants required;

Countries

China

Contacts

Public ContactTianxin Chen

The First Affiliated Hospital of Wenzhou Medical University

ctxzjf@163.com+86 577 5557 8056

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026