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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT00426348
First received: January 23, 2007
Last updated: January 6, 2012
Last verified: January 2012
History of Changes

January 23, 2007
January 6, 2012
May 2007
May 2012   (final data collection date for primary outcome measure)
urinary protein loss whithin 24 hours [ Time Frame: 2-3years ] [ Designated as safety issue: No ]
proteinuria
Complete list of historical versions of study NCT00426348 on ClinicalTrials.gov Archive Site
renal function(serum Crea or eGFR) deterioration [ Time Frame: 2-3years ] [ Designated as safety issue: No ]
renal function deterioration
Not Provided
Not Provided
 
A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Glomerulonephritis
  • IGA Nephropathy
  • Drug: Valsartan
    Valsartan (80-160mg/day)
    Other Name: Valsartan
  • Drug: Probucol
    Probucol (750mg/day)
  • Drug: Placebo
    Placebo
  • Active Comparator: 1
    In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
    Interventions:
    • Drug: Valsartan
    • Drug: Placebo
  • Experimental: 2
    Valsartan(80-160mg/day) + Probucol(750mg/day)
    Interventions:
    • Drug: Valsartan
    • Drug: Probucol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00426348
GPPH200603
Yes
Wei Shi, Guangdong General Hospital
Guangdong General Hospital
Not Provided
Principal Investigator: Wei Shi, PhD,MD Nephrology Dept.,Guangdong General Hospital
Guangdong General Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP