The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Patients With Persistent Proteinuria

Samsung Medical Center500 enrolled

Overview

This study is a multicenter, prospective, interventional study. It does not have a control group. All participants will receive 160 mg valsartan for 8 weeks. Among them, the patients with persistent proteinuria (defined as proteinuria more than 1 g/g after 8 weeks treatment of valsartan) will receive 320 mg valsartan for further 16 weeks. Participants who did not receive any ACEI or ARB previously will have a titration period for 4 weeks (80 mg for 4 weeks, 160 mg for 4 weeks, and then 320 mg for 16 weeks). The investigators will evaluate the change of urinary angiotensinogen excretion between at baseline, at 8 weeks, and 24 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

500

Conditions

Chronic Kidney Disease Proteinuria

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic kidney disease patients with * proteinuria of 1 - 10 g/day, * stable and controlled blood pressure (100/60 mmHg - 160/100 mmHg), * stable renal function with GFR ≥ 30 mL/min/ m2, * diabetes or non-diabetes Exclusion Criteria: * Uncontrolled diabetes (defined as HbA1c \> 9.0%) * Immunosuppressive treatment within 6 months * Intractable edema * Hyperkalemia (\>5.5 mEq/L) or Hypokalemia (\< 3.5 mEq/L)

Outcomes

Primary Outcomes

The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.

Time frame: 4 weeks of screening periods + 24 weeks of treatment