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

NCT07151456 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: KY2025-303
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• Relapse

  Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria.

  through study completion, an average of 2 years

Secondary Outcomes (1)

• Relapse rate

  12 months，24 months

Study Arms (2)

conventional course prednisolone arm

ACTIVE COMPARATOR

Drug: Conventional 24-week glucocorticoid regimen

short-term course prednisolone arm

EXPERIMENTAL

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

Interventions

Conventional 24-week glucocorticoid regimen DRUG

Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5 - 6: Prednisolone 0.8mg/kg/day (max 60mg); Weeks 7 - 8: Prednisolone 0.6mg/kg/day (max 50mg); Weeks 9 - 10: Prednisolone 0.5mg/kg/day (max 40mg); Weeks 11 - 12: Prednisolone 0.4mg/kg/day (max 30mg); Weeks 13 - 16: Prednisolone 0.3mg/kg/day (max 25mg); Weeks 17 - 20: Prednisolone 0.2mg/kg/day (max 15 Weeks 21 - 24: Prednisolone 0.1mg/kg/day (max 10mg).

conventional course prednisolone arm

short-term course (12 week) glucocorticoid regimen DRUG

Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5-8: Prednisolone 1mg/kg/day (max 80mg) on alternate days; 9-12: Prednisolone 0.5mg/kg/day (max 40mg) on alternate days

short-term course prednisolone arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (8)

• Evans JHC, Long E. A national audit of nephrotic syndrome: The initial course of prednisolone and outcome. Abstract. Ped Nephrol 1998;12(7):C154

  BACKGROUND

• Hodson EM, Knight JF, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2004;(2):CD001533. doi: 10.1002/14651858.CD001533.pub2.

  PMID: 15106158 BACKGROUND

• Ksiazek J, Wyszynska T. Short versus long initial prednisone treatment in steroid-sensitive nephrotic syndrome in children. Acta Paediatr. 1995 Aug;84(8):889-93. doi: 10.1111/j.1651-2227.1995.tb13787.x.

  PMID: 7488812 BACKGROUND

• Bargman JM. Management of minimal lesion glomerulonephritis: evidence-based recommendations. Kidney Int Suppl. 1999 Jun;70:S3-16. doi: 10.1046/j.1523-1755.1999.07002.x.

  PMID: 10369190 BACKGROUND

• Abramowicz M, Barnett HL, Edelmann CM Jr, Greifer I, Kobayashi O, Arneil GC, Barron BA, Gordillo-P G, Hallman N, Tiddens HA. Controlled trial of azathioprine in children with nephrotic syndrome. A report for the international study of kidney disease in children. Lancet. 1970 May 9;1(7654):959-61. doi: 10.1016/s0140-6736(70)91093-7. No abstract available.

  PMID: 4191931 BACKGROUND

• Brodehl J. Conventional therapy for idiopathic nephrotic syndrome in children. Clin Nephrol. 1991;35 Suppl 1:S8-15.

  PMID: 1860269 BACKGROUND

• Consensus statement on management and audit potential for steroid responsive nephrotic syndrome. Report of a Workshop by the British Association for Paediatric Nephrology and Research Unit, Royal College of Physicians. Arch Dis Child. 1994 Feb;70(2):151-7. doi: 10.1136/adc.70.2.151. No abstract available.

  PMID: 8129444 BACKGROUND

• Trompeter RS, Lloyd BW, Hicks J, White RH, Cameron JS. Long-term outcome for children with minimal-change nephrotic syndrome. Lancet. 1985 Feb 16;1(8425):368-70. doi: 10.1016/s0140-6736(85)91387-x.

  PMID: 2857421 BACKGROUND

MeSH Terms

Conditions

Nephrosis, Lipoid

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)