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

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: Chronic Kidney Disease; Proteinuria

Treatments: Drug: valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT00858299

2008-07-089

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

valsartan

Experimental group

Treatment:

Drug: valsartan