Probucol Combined With Valsartan in Reducing Proteinuria in Diabetes Nephropathy

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

Status: Unknown

Conditions: Nephropathy; Type 2 Diabetes Mellitus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00655330

GPPH200603 -1

Details and patient eligibility

About

This is a prospective randomized controlled, open-labeled study to identify the efficacy of probucol in combination with valsartan in patients with Diabetes nephropathy. The reduction of urinary albumin or proteinuria will be the primary outcome studied. The expected study duration will be 48 weeks.

Full description

a prospective randomized controlled, open-labeled study in patients with Diabetes nephropathy

• Arm 1: Valsartan + Probucol Valsartan (160mg/day) + Probucol (750mg/day)
• Arm 2: Valsartan + Placebo Valsartan (160mg/day) + Placebo

Enrollment: 170 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes nephropathy
• Urinary albumin excretion 1-3g/24hours
• Serum creatinine < 3mg/dl

Exclusion criteria

• Type 1 diabetes mellitus
• Renal diseases other than type 2 Diabetes nephropathy
• Renal artery stenosis
• Severe heart diseases
• Tuberculosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 2 patient groups

1

Active Comparator group

Description:

Valsartan (160mg/day)is given in combination with Placebo

Treatment:

Drug: Placebo

Drug: Valsartan

2

Experimental group

Description:

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

Treatment:

Drug: Probucol

Drug: Valsartan