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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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12 December 2020 |
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Main ID: |
NCT03468972 |
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Date of registration:
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12/03/2018 |
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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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Effect of Immunosuppression in IgA Nephropathy
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Scientific title:
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Effect of Immunosuppression in IgA Nephropathy |
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Date of first enrolment:
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March 2019 |
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Target sample size:
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174 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03468972 |
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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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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Seung Hyeok Han, MD, Ph.D |
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Address:
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Telephone:
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82-2-2228-1984 |
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Email:
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hansh@yuhs.ac |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biopsy-proven IgA nephropathy within 5 years of enrollment
- Persistent proteinuria of UPCR = 1.0 g/g creatinine during 12-week supportive care
including RAS blockers
- baseline eGFR = 30 ml/min/1.73 m2 assessed by CKD-EPI equation
Exclusion Criteria:
- Nephrotic syndrome, atypical IgA nephropathy
- Crescents = 25%
- Overt pulmonary tuberculosis
- Malignancy within 5 years of enrollment
- Pregnancy or breast feeding
- Active hepatitis, chronic hepatitis, liver cirrhosis, HIV
- Kidney transplant
- Current use of immunosuppressive treatment or prior use of immunosuppressive drugs
within 1 year of enrollment
- Uncontrolled hypertension (> 160/100 mmHg)
- Aged < 19 years
- Secondary IgA nephropathy such as lupus nephritis, chronic liver disease, or
Henoch-Schlein purpura
- Involvement of other clinical trials within 3 months of enrollment
Age minimum:
19 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Biopsy-proven IgA Nephropathy
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Intervention(s)
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Other: intensive supportive care
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Drug: Immunosuppressive treatment
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Primary Outcome(s)
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progression of disease
[Time Frame: 6 months]
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progression of disease
[Time Frame: 36 months]
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Secondary Outcome(s)
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Changes in urinary protein excretion and hematuria
[Time Frame: 6 months]
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Changes in urinary protein excretion and hematuria
[Time Frame: 36 months]
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Secondary ID(s)
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4-2018-0303
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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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