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

Phase 4

Completed

• Conditions: Glomerulonephritis; IGA Nephropathy
• Interventions: Drug: Valsartan; Drug: Placebo; Drug: Probucol

• Registration Number: NCT00426348
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-24
• Study Start: 2007-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
2	Valsartan	Valsartan(80-160mg/day) + Probucol(750mg/day)
1	Valsartan	In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
2	Probucol	Valsartan(80-160mg/day) + Probucol(750mg/day)

Primary Outcome Measures

Name	Time	Method
urinary protein loss whithin 24 hours	2-3years

Secondary Outcome Measures

Name	Time	Method
renal function(serum Crea or eGFR) deterioration	2-3years

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China