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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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31 August 2015 |
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Main ID: |
NCT02529722 |
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Date of registration:
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07/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Biomarkers for the Progression of IgA Nephropathy
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Scientific title:
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Histological and Clinical Biomarkers to Predict the Progression of IgA Nephropathy |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02529722 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Yasar Caliskan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with biopsy-proven IgA nephropathy (defined by standard criteria)
- Patients at all ages will be included regardless of treatment given
- A renal biopsy available for reviewing must include 8 or more glomeruli.
- At least 3 measurements of blood pressure, serum creatinine and proteinuria have to
be performed.
- The first measurement should be within 3 months of the date of renal biopsy and the
last at the end of the follow-up.
- Patients must comply with the following criteria
1. have a follow-up longer than 1 year
2. or having progressed to end-stage renal disease regardless of the duration of
follow-up.
- Patients who have received antihypertensive or immunosuppressive medication will be
included as well.
Exclusion Criteria:
- Diabetes at the time of first kidney biopsy.
- Solid organ (other than kidney) or bone marrow transplant at the time of biopsy.
- Other pre-existing parenchymal kidney disease on first kidney biopsy, determined by
the pathology examination.
- Diagnosis of any of the following diseases from the time of biopsy to the time of
enrollment: Systemic lupus erythematosus, HIV infection, active malignancy, except
for non-melanoma skin cancer, active hepatitis B or C infection, defined as positive
viral load
- Patients with life expectancy < 6 months
- Patients who are unwilling or unable to consent.
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glomerular Diseases
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IgA Nephropathy
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Primary Outcome(s)
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Progression to end stage renal disease or two-fold increase in serum creatinine level as compared to baseline
[Time Frame: 36 months]
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Secondary Outcome(s)
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Resistance of proteinuria
[Time Frame: 36 months]
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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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