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

Wenzhou Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Idiopathic Nephrotic Syndrome

Treatments: Drug: short-term course (12 week) glucocorticoid regimen; Drug: Conventional 24-week glucocorticoid regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT07151456

KY2025-303

Details and patient eligibility

About

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

conventional course prednisolone arm

Active Comparator group

Treatment:

Drug: Conventional 24-week glucocorticoid regimen

short-term course prednisolone arm

Experimental group

Treatment:

Drug: short-term course (12 week) glucocorticoid regimen