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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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27 March 2023 |
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Main ID: |
NCT05667883 |
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Date of registration:
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07/12/2022 |
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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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Prognostic Model of GC/CTX in the Treatment of MN
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Scientific title:
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Development and Validation of a Prognostic Model for Idiopathic Membranous Nephropathy Treated With Glucocorticoids Plus Cytoxan |
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Date of first enrolment:
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June 2023 |
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Target sample size:
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50 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT05667883 |
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Study type:
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Observational |
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Study design:
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Phase:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or
anti phospholipase A2 receptor (PLA2R) antibody positive by renal puncture biopsy, and
the clinical data were complete;
2. According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines in 2020,
it conforms to the medium and high risks in the risk level of progression of renal
function loss.
3. In general, they are in good condition, have a good understanding of their own
conditions and physical conditions, have self-awareness, and can communicate well with
others;
4. Volunteer to participate in the study, understand the significance of this experiment
and the indicators to be measured, and sign the informed consent form.
Exclusion Criteria:
1. There are factors causing secondary membranous nephropathy, such as immune diseases
(systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;
2. At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute
nephritis and other renal pathological types were combined;
3. The medication was not standardized during the treatment process, accompanied by
serious infection, acute renal injury and other complications, and serious
cardiovascular, cerebrovascular, digestive and blood system diseases;
4. During follow-up, the patient cannot actively cooperate or accurately understand and
express.
Age minimum:
18 Years
Age maximum:
75 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: glucocorticoid + cytoxan
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Primary Outcome(s)
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Remission
[Time Frame: 6 months]
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Secondary ID(s)
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IMN-GC/CTX
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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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