Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study

Not Applicable

Not yet recruiting

• Conditions: Idiopathic Nephrotic Syndrome
• Interventions: Drug: Conventional 24-week glucocorticoid regimen; Drug: short-term course (12 week) glucocorticoid regimen

• Registration Number: NCT07151456
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

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-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2026-01-01
• Primary Completion: 2029-12
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional course prednisolone arm	Conventional 24-week glucocorticoid regimen	-
short-term course prednisolone arm	short-term course (12 week) glucocorticoid regimen	-

Primary Outcome Measures

Name	Time	Method
Relapse	through study completion, an average of 2 years	Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria.

Secondary Outcome Measures

Name	Time	Method
Relapse rate	12 months，24 months	the proportion of adults who develop relapsing

Trial Locations

Locations (1)

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China