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

This study has been completed.
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital Identifier:
First received: January 23, 2007
Last updated: August 27, 2013
Last verified: August 2013

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.

Condition Intervention Phase
Glomerulonephritis IGA Nephropathy Drug: Valsartan Drug: Probucol Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

Resource links provided by NLM:

Further study details as provided by Wei Shi, Guangdong General Hospital:

Primary Outcome Measures:
  • urinary protein loss whithin 24 hours [ Time Frame: 2-3years ]

Secondary Outcome Measures:
  • renal function(serum Crea or eGFR) deterioration [ Time Frame: 2-3years ]

Enrollment: 75
Study Start Date: May 2007
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
Drug: Valsartan
Valsartan (80-160mg/day)
Drug: Placebo
Experimental: 2
Valsartan(80-160mg/day) + Probucol(750mg/day)
Drug: Valsartan
Valsartan (80-160mg/day)
Drug: Probucol
Probucol (750mg/day)


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
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Please refer to this study by its identifier: NCT00426348

China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong General Hospital
Principal Investigator: Wei Shi, PhD,MD Nephrology Dept.,Guangdong General Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong General Hospital Identifier: NCT00426348     History of Changes
Other Study ID Numbers: GPPH200603
Study First Received: January 23, 2007
Last Updated: August 27, 2013

Keywords provided by Wei Shi, Guangdong General Hospital:
IgA nephropathy
IGA nephropathy:a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents processed this record on September 19, 2017