A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
NCT ID: NCT00426348
Last Updated: 2013-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2007-05-31
2013-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
Valsartan
Valsartan (80-160mg/day)
Placebo
Placebo
2
Valsartan(80-160mg/day) + Probucol(750mg/day)
Valsartan
Valsartan (80-160mg/day)
Probucol
Probucol (750mg/day)
Interventions
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Valsartan
Valsartan (80-160mg/day)
Probucol
Probucol (750mg/day)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Responsible Party
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Wei Shi
Director of renal division of Guangdong General Hospital
Principal Investigators
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Wei Shi, PhD,MD
Role: PRINCIPAL_INVESTIGATOR
Nephrology Dept.,Guangdong General Hospital
Locations
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Guangdong General Hospital
Guangzhou, Guangdong, China
Countries
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References
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Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Ye Z, Zhang L, Xu L, Shi W, Hu H, Shi X, Zhong W, Hou S, Yan H, Zhang B, Xia Y, Wang W, Feng Z, Wang L, Liang Y. Probucol combined with valsartan in immunoglobulin A nephropathy: a multi-centre, open labelled, randomized controlled study. Nephrology (Carlton). 2014 Jan;19(1):40-6. doi: 10.1111/nep.12177.
Other Identifiers
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GPPH200603
Identifier Type: -
Identifier Source: org_study_id