The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Group prednisone Prednisone was taken 1mg/kg/d(maximum 60mg/d)for 8 weeks to start.Then decreased 5mg every 2 weeks; When reduced to 40mg,reduced 5mg every 4 weeks. When reduced to 20mg, reduced 2.5mg every 8 weeks until the end. |
Drug: Prednisone
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.
Other Names:
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Active Comparator: Group MP and CTX The first month,Methylprednisolone(MP) was injected for 3 days(weight >60kg,500mg/d;<60 kg,300mg/d),and 0.4mg/kg/d for 27 day.The second month,Cyclophosphamide(CTX) orally was 100mg/d for 1 month.And this regimen is repeated for six months. |
Drug: MP 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- nephrotic syndrome remission ( including complete remission and partial remission) [12 months]
nephrotic syndrome remission ( including complete remission and partial remission)
Secondary Outcome Measures
- blood albumin≥30g/L [12 months]
blood albumin≥30g/L
Eligibility Criteria
Criteria
Inclusion Criteria:
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The pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy
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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:
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Secondary membranous nephropathy
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Serious complications
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Beijing Friendship Hospital, Capital Medical University | Beijing | China | 100050 |
Sponsors and Collaborators
- Wenhu Liu
Investigators
- Study Chair: Wenhu Liu, doctor, Beijing Friendship Hospital
- Study Director: Zongli Diao, Beijing Friendship Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-P2-172-02