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

IGA Nephropathy Clinical Trial

Official title:

A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426348
• Other study ID #: GPPH200603
• Status: Completed
• Phase: Phase 4
• First received: January 23, 2007
• Last updated: August 27, 2013
• Start date: May 2007
• Est. completion date: January 2013

Study information

• Verified date: August 2013
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA
• IGA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Valsartan
Valsartan (80-160mg/day)
• Probucol
Probucol (750mg/day)
• Placebo
Placebo

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary protein loss whithin 24 hours		2-3years	No
Secondary	renal function(serum Crea or eGFR) deterioration		2-3years	No