Idiopathic Membranous Nephropathy
Conditions
Keywords
prednisone alone, methylprednisolone and cyclophosphamide, membranous nephropathy in stage I
Brief summary
Multi-center, prospective, randomized, controlled study to verify the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of stage I membranous nephropathy.
Detailed description
Idiopathic membranous nephropathy (IMN) is one of the most common cause of adult nephrotic syndrome. Prednisolone and methylprednisolone are essential drugs for IMN. However, there are no recommendations for the treatment of IMN in China. KDIGO guidelines recommend combination therapy with methylprednisolone and cyclophosphamide as first-line therapy of IMN, but there is a large side effect of cyclophosphamide.There were retrospective study showed that the use of glucocorticoid hormones (including prednisone and methylprednisolone) alone may be effective in patients with membranous nephropathy in Asia, but there is no high quality evidence of evidence-based medicine.The study is a randomized prospective controlled multi-centered trial,to compare the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of membranous nephropathy in stage I.
Interventions
DRUGPrednisone
Prednisone was taken for oral administration with dosage of 1mg/kg/d (maximum 60mg/d) by 8 weeks to start.Then reduced Gradually until the end of the experiment.
DRUGMP and CTX
Methylprednisolone(MP) was injected for 3 day(if weight \>60kg ,500mg/d\<60kg,300mg/d ), methylprednisolone was 0.4mg/kg/d for 27 day.Cyclophosphamide(CTX) orally was 100mg/ d for 1 month.And repeated for six months.
Sponsors
Wenhu Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy 2. Meeting one of the following three condition： * Urine protein quantitation \>4g/d,or 50% higher than baseline,RASS blocker treat for 6 months without trend of decrease ②Serious or disabling complications related to nephrotic syndrome ③In the 6-12 months after diagnosis of idiopathic membranous nephropathy, serum creatinine increased by more than 30%, while eGFR eGFR≥25ml/min/1.73m2.And excludeing other causes of renal dysfunction
Exclusion criteria
1. Secondary membranous nephropathy 2. Serious complications 3. Considering the effect of cyclophosphamide on the of function of sex gland，all patients with childbearing age or fertility requirement cannot participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| nephrotic syndrome remission ( including complete remission and partial remission) | 12 months | nephrotic syndrome remission ( including complete remission and partial remission) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood albumin≥30g/L | 12 months | blood albumin≥30g/L |
Countries
China
Outcome results
None listed