A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

Study Overview
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Brief Summary
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a statement of the study hypothesis:the effect of valsartan in patients with IgA nephropathy have been proved,and the efficacy of probucol in combination with valsartan is to be proved in patients with IgA nephropathy. This is a prospective randomized controlled, double blinded pilot study to identify the efficacy of probucol in combination with valsartan in patients with IgA nephropathy. The renal function deterioration will be the primary outcome studied. The expected study duration will be 36 months.

Official Title
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A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

Conditions
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Glomerulonephritis, IGA Nephropathy

Intervention / Treatment
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* Drug: Valsartan
* Drug: Probucol
* Drug: Placebo


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo | Drug: Valsartan<br>* Valsartan (80-160mg/day)<br>Drug: Placebo<br>* Placebo<br>|
| Experimental: 2<br>Valsartan(80-160mg/day) + Probucol(750mg/day) | Drug: Valsartan<br>* Valsartan (80-160mg/day)<br>Drug: Probucol<br>* Probucol (750mg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary protein loss whithin 24 hours |  | 2-3years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function(serum Crea or eGFR) deterioration |  | 2-3years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgA nephropathy, probucol, valsartan, treatment, antioxidant, IGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas