Clinical trial NCT03466801: The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.
Official title: The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Idiopathic Membranous Nephropathy
Keywords: prednisone alone
methylprednisolone and cyclophosphamide
membranous nephropathy in stage I
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: nephrotic syndrome remission ( including complete remission and partial remission)
timeFrame: 12 months
Secondary outcomes:
measure: blood albumin≥30g/L
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
affiliation: Beijing Friendship Hospital
name: Wenhu Liu, doctor
role: STUDY_CHAIR
affiliation: Beijing Friendship Hospital
name: Zongli Diao
role: STUDY_DIRECTOR
References: