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

NCT07151456 — Phase 4, Not yet recruiting, 224 participants, First Affiliated Hospital of Wenzhou Medical University

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

Registry	NCT07151456
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	224 (Estimated)
Sponsor	First Affiliated Hospital of Wenzhou Medical University (Other)
Conditions	Idiopathic Nephrotic Syndrome
Interventions	Conventional 24-week glucocorticoid regimen, short-term course (12 week) glucocorticoid regimen (Drug)
Dates	start 2026-01-01 (estimated), primary completion 2029-12-01 (estimated), completion 2029-12-01 (estimated), first posted 2025-09-03, last updated 2025-09-03
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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

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).
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

+Outcome measures

Primary outcomes

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 outcomes

Relapse rate [12 months，24 months]: the proportion of adults who develop relapsing

+Eligibility

Sex: All, ages: 16 Years to any

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

+Locations (1)

Facility	City	Country	Status
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou, Zhejiang	China

+Publications

Evans JHC, Long E. A national audit of nephrotic syndrome: The initial course of prednisolone and outcome. Abstract. Ped Nephrol 1998;12(7):C154
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
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
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
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
Brodehl J. Conventional therapy for idiopathic nephrotic syndrome in children. Clin Nephrol. 1991;35 Suppl 1:S8-15. PMID 1860269
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
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