drugset / Trial / NCT07151456
Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2026-01
- Primary completion
- 2029-12
- Completion
- 2029-12
Publications
- Background 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.
- 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.
- 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.
- 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.
- Background Brodehl J. Conventional therapy for idiopathic nephrotic syndrome in children. Clin Nephrol. 1991;35 Suppl 1:S8-15.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisolone | Other / unclassified | 0.1 mg/kg | — |
| Comparator | Prednisolone | Other / unclassified | 0.5 mg/kg | — |