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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: |
NCT03218852 |
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Date of registration:
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07/12/2016 |
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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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Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
e-TOPplus |
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Scientific title:
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An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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133 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03218852 |
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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: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- biopsy-proven primary IgA nephropathy
- 18-70 years old
- elevated serum Creatinine and less than 3.0mg/dl
- with a written consent from participants to receive prednisone and/or cyclophosphamide
Exclusion Criteria:
- diabetes;
- contraindications for the treatment of prednisone and/or cyclophosphamide
- any treatment with steroids or immunosuppressive drugs prior to this study
- acute deterioration of renal function(including those of glomerular origin)
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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IgA Nephropathy
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Intervention(s)
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Drug: prednisone alone
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Drug: prednisone and cyclophosphamide
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Primary Outcome(s)
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the changes of kidney function or death
[Time Frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)]
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Secondary Outcome(s)
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the changes of proteinuria
[Time Frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)]
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Number of Participants with Adverse Events
[Time Frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)]
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Secondary ID(s)
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GGH2012-36-1
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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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