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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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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2017/02/007768 |
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Date of registration:
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03-02-2017 |
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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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Role of steroids in IgA nephropathy and correlation with Oxford MEST Classification
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Scientific title:
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A longitudinal observational study of clinical spectrum of IgA nephropathy and its co-relation to histopathology and outcome |
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Date of first enrolment:
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17-02-2015 |
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Target sample size:
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30 |
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Recruitment status: |
Open to Recruitment |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14981 |
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Study type:
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Observational |
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Study design:
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Single Arm Trial
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Smita S Divyaveer
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Address:
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Department of nephrology,
IPGMER and SSKM Hospital,
Kolkata,
West Bengal.
700020
Kolkata, WEST BENGAL
India |
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Telephone:
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Email:
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rajensankrityan@gmail.com |
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Affiliation:
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IPGMER KOLKATA |
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Name:
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Rajendra Pandey
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Address:
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Department of nephrology,
IPGMER and SSKM Hospital,
Kolkata,
West Bengal.
700020
Kolkata, WEST BENGAL
India |
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Telephone:
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Email:
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rajensankrityan@gmail.com |
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Affiliation:
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IPGMER KOLKATA |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients diagnosed with Primary IgA nephropathy on kidney biopsy.
Exclusion criteria: 1)Patients with secondary IgA Nephropathy.
2)Patients with Henoch Schonlein Purpura ( HSP )
3)Patients with concomitant diseases that affect the progression of kidney disease.
4)Patients not giving consent or unwilling to participate in the study.
5)Pregnant patients
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: N08- Glomerular disorders in diseases classified elsewhere
Health Condition 2: null- Primary Immunoglobulin A Nephropathy
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Primary Outcome(s)
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Complete clinical remission,
Complete Protienuria remission,
Partial Proteinuria remission,
End Stage Renal Disease,
Death due to any cause.
Timepoint: 3 monthly intervals till the end of study
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Secondary Outcome(s)
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50% or more decline of eGFRTimepoint: 3 monthly intervals
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Source(s) of Monetary Support
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Department of nephrology,IPGMER, Kolkata
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Ethics review
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Status: Approved
Approval date: 16/02/2015
Contact:
IPGMER RESEARCH OVERSIGHT COMMITTEE (INSTITUTIONAL ETHICS COMMITTEE)
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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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