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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: |
NCT00426348 |
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Date of registration:
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23/01/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
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Scientific title:
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A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00426348 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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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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Contacts
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Name:
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Wei Shi, PhD,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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Nephrology Dept.,Guangdong General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who fulfill the clinical and pathological criteria for IgA nephropathy
- Age: 18-60 years
- Renal biopsy diagnostic for IgA nephropathy based on immunohistologic staining for
IgA that is greater than or equal to staining for IgG and IgM
- Urinary protein excretion rate is within the range of 1-2.5g/day
- Serum creatinine <265.2umol/L at the time of randomization
Exclusion Criteria:
- Patients who refuse to be randomized for treatment
- Patients who prefer treatment with conventional agents
- Patients who are pregnant or plan for pregnancy
- Patients who are pathologically proven severely or diffusely proliferative IgA
nephropathy or crescent glomerulonephritis with >= 50% segmental involvement of the
glomeruli and should be treated with other agents,such as immunosuppressive agents or
steroid
- Clinical and histologic evidence of:
- systemic lupus erythematosus
- Henoch-Schonlein purpura
- cirrhosis
- chronic active liver disease
- hepatitis B
- hepatitis C
- severe chronic diarrhea
- active peptic ulcer disease
- HIV
- acute renal failure
- malignant hypertension
- severe heart diseases
- malignant tumor
- any systemic infection
- pregnancy
- Known contraindication to the administration of probucol and valsartan
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IGA Nephropathy
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Glomerulonephritis
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Intervention(s)
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Drug: Placebo
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Drug: Probucol
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Drug: Valsartan
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Primary Outcome(s)
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urinary protein loss whithin 24 hours
[Time Frame: 2-3years]
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Secondary Outcome(s)
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renal function(serum Crea or eGFR) deterioration
[Time Frame: 2-3years]
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Secondary ID(s)
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GPPH200603
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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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