The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.

Wenhu Liu6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Idiopathic Membranous Nephropathy

Interventions

PrednisoneDRUG

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.

MP and CTXDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

nephrotic syndrome remission ( including complete remission and partial remission)

Time frame: 12 months

Secondary Outcomes

blood albumin≥30g/L

Time frame: 12 months

Data from ClinicalTrials.gov

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