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

Phase 4
Conditions
Chronic Kidney Disease
Proteinuria
Interventions
Registration Number
NCT00858299
Lead Sponsor
Samsung Medical Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
500
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
valsartanvalsartan-
Primary Outcome Measures
NameTimeMethod
The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.4 weeks of screening periods + 24 weeks of treatment
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Division of Nephrology, Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

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