Idiopathic Nephrotic Syndrome
Conditions
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.
Interventions
DRUGConventional 24-week glucocorticoid regimen
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).
DRUGshort-term course (12 week) glucocorticoid regimen
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
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate | 12 months，24 months | the proportion of adults who develop relapsing |
Countries
China
Outcome results
None listed