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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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16 December 2017 |
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Main ID: |
NCT01197040 |
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Date of registration:
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07/09/2010 |
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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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Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome
MSN |
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Scientific title:
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Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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117 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01197040 |
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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 3
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe REMY, 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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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Idiopathic nephrotic syndrome
- Flare of idiopathic syndrome without treatment from one year
- Confirming by Renal Biopsy
Exclusion Criteria:
- Secondary nephrotic syndrome
- Pregnancy
- Focal Segmental Glomerular sclerosis lesion in the Biopsy
- Neutropenia < 2000/mm3
- Hb<9gr/dl
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Nephrotic Syndrome
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Intervention(s)
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Drug: acid mycophenolic (Myfortic)
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Drug: Prednisone
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Primary Outcome(s)
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complete remission
[Time Frame: within 4 weeks]
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Secondary Outcome(s)
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Adverse effects in both arms
[Time Frame: 1 year]
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Number of flare in both arms
[Time Frame: at 1 year]
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complete remission
[Time Frame: within 8 weeks]
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partial remission
[Time Frame: within 4 and 8 weeks]
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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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