Official Title: “A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2010

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

Outcome Measure: renal function deterioration

Intervention(s) in this Clinical Trial

• Drug: Valsartan + Placebo
  • Valsartan (80-160mg/day) + Placebo
• Drug: Valsartan + Probucol
  • Valsartan (80-160mg/day) + Probucol (750mg/day)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Valsartan(80-160mg/day) + Placebo
• Experimental: 2
  • Valsartan(80-160mg/day) + Probucol(750mg/day)

Primary Measures

• proteinuria
  • Time Frame: 2-3years
    Safety Issue?: No

Secondary Measures

• renal function deterioration
  • Time Frame: 2-3years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Guangdong Provincial People's Hospital

Overall Clinical Trial Officials and Contacts

Wei Shi, PhD,MD Principal Investigator Nephrology Dept.,Guangdong Provincial People's Hospital  

Overall Contact: Wei Shi, PhD,MD 86-20-8385-0849 weishi_gz@126.com

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00426348

Study ID Number: GPPH200603

ClinicalTrials.gov Identifier: NCT00426348

Health Authority: China: Ethics Committee