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

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ClinicalTrials.gov Identifier: NCT00426348
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong Provincial People's Hospital

Study Description
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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 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 or disease Intervention/treatment Phase
Glomerulonephritis IGA Nephropathy Drug: Valsartan Drug: Probucol Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
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
Study Start Date : May 2007
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Arms and Interventions
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Arm Intervention/treatment
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
Placebo
Experimental: 2
Valsartan(80-160mg/day) + Probucol(750mg/day)
 Drug: Valsartan
Valsartan (80-160mg/day)

Drug: Probucol
Probucol (750mg/day)


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426348


Locations
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China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
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Principal Investigator: Wei Shi, PhD,MD Nephrology Dept.,Guangdong General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT00426348    
Other Study ID Numbers: GPPH200603
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by Wei Shi, Guangdong Provincial People's Hospital:
IgA nephropathy
probucol
valsartan
 treatment
antioxidant
IGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Glomerulonephritis
Urologic Diseases
Nephritis
Autoimmune Diseases
Immune System Diseases
Valsartan
Probucol
Antihypertensive Agents
 Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Antioxidants
Protective Agents
Physiological Effects of Drugs