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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 February 2022 |
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Main ID: |
NCT03466801 |
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Date of registration:
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13/01/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Efficacy of Prednisone and Combination Therapy With Methylprednisolone and Cyclophosphamide on IMN in Stage I.
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Scientific title:
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The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I. |
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Date of first enrolment:
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March 20, 2018 |
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Target sample size:
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6 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03466801 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Zongli Diao |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Friendship Hospital |
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Name:
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Wenhu Liu, doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Friendship Hospital |
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Key inclusion & exclusion criteria
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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 ?Serious or disabling complications
related to nephrotic syndrome ?In 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Membranous Nephropathy
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Intervention(s)
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Drug: Prednisone
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Drug: MP and CTX
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Primary Outcome(s)
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nephrotic syndrome remission ( including complete remission and partial remission)
[Time Frame: 12 months]
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Secondary Outcome(s)
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blood albumin=30g/L
[Time Frame: 12 months]
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Secondary ID(s)
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2017-P2-172-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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