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

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00426348

Collaborator

(none)

Enrollment

Location

Arms

68.1

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 1, 2007

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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)

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

Primary Outcome Measures

urinary protein loss whithin 24 hours [2-3years]

Secondary Outcome Measures

renal function(serum Crea or eGFR) deterioration [2-3years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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