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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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19 February 2015 |
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Main ID: |
NCT01392833 |
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Date of registration:
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05/07/2011 |
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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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Steroids and Azathioprine in Advanced IgAN
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Scientific title:
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Steroids and Azathioprine in Early and Advanced IgA Nephropathy: Amendments to a Prospective Randomised Multicenter Trial |
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Date of first enrolment:
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December 1999 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01392833 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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claudio pozzi, 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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A. Manzoni Hospital, ospedale G. bassini |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Serum creatinine higher or equal to 2.0 mg/dl
- Proteinuria higher or equal to 1g/24g for at least three months
- No time limits for renal biopsy
Exclusion Criteria:
- Steroids and/or cytotoxic drugs (used for more than three months) in the previous
three years
- Contraindications to steroids or azathioprine
- Diabetes
- Severe hypertension (diastolic blood pressure > 120 mmHg)
- Liver disease
- Infections
- Active peptic-ulcer disease
- Malignancies
- Pregnancy
- Secondary IgAN
Age minimum:
16 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgA Nephropathy
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Chronic Kidney Disease
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Intervention(s)
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Drug: prednisone
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Drug: azathioprine
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Drug: methylprednisolone
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Primary Outcome(s)
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renal survival
[Time Frame: five years]
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Secondary Outcome(s)
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proteinuria
[Time Frame: at six month and during follow up]
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adverese events (possible treatment related)
[Time Frame: 5 years]
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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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