Status:
COMPLETED
A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Glomerulonephritis
IGA Nephropathy
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00426348
Start Date
May 1 2007
End Date
January 1 2013
Last Update
August 28 2013
Active Locations (1)
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1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080