Back to resultsThe Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.
Primary Purpose
Idiopathic Membranous Nephropathy
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisone
MP and CTX
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Membranous Nephropathy focused on measuring prednisone alone, methylprednisolone and cyclophosphamide, membranous nephropathy in stage I
Eligibility Criteria
Inclusion Criteria:
- The pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy
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:
- Secondary membranous nephropathy
- Serious complications
- 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
Sites / Locations
- Beijing Friendship Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group prednisone
Group MP and CTX
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
nephrotic syndrome remission ( including complete remission and partial remission)
nephrotic syndrome remission ( including complete remission and partial remission)
Secondary Outcome Measures
blood albumin≥30g/L
blood albumin≥30g/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03466801
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
the clinical significance is little
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenhu Liu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Membranous Nephropathy
Keywords
prednisone alone, methylprednisolone and cyclophosphamide, membranous nephropathy in stage I
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group prednisone
Arm Type
Experimental
Arm Description
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.
Arm Title
Group MP and CTX
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Glucocorticoid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MP and CTX
Other Intervention Name(s)
Glucocorticoid and immunosuppressive agents
Intervention Description
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.
Primary Outcome Measure Information:
Title
nephrotic syndrome remission ( including complete remission and partial remission)
Description
nephrotic syndrome remission ( including complete remission and partial remission)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
blood albumin≥30g/L
Description
blood albumin≥30g/L
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy
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:
Secondary membranous nephropathy
Serious complications
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhu Liu, doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zongli Diao
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.
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