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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Completed; Phase 4

Conditions: Glomerulonephritis; IGA Nephropathy

Treatments: Drug: Probucol; Drug: Placebo; Drug: Valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT00426348

GPPH200603

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups

1

Active Comparator group

Description:

In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo

Treatment:

Drug: Valsartan

Drug: Placebo

2

Experimental group

Description:

Valsartan(80-160mg/day) + Probucol(750mg/day)

Treatment:

Drug: Valsartan

Drug: Probucol