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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease Proteinuria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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valsartan

Group Type EXPERIMENTAL

valsartan

Intervention Type DRUG

160 mg oral once in a day for initial 8 weeks and 320 mg, oral, once in a day for subsequent 16 weeks

Interventions

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valsartan

160 mg oral once in a day for initial 8 weeks and 320 mg, oral, once in a day for subsequent 16 weeks

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No