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

Primary Purpose

Chronic Kidney Disease, Proteinuria

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
valsartan
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Kidney Disease focused on measuring proteinuria, chronic kidney disease, renin-angiotensin system, angiotensinogen

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Division of Nephrology, Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

valsartan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 5, 2009
Last Updated
March 6, 2009
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00858299
Brief Title
The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Patients With Persistent Proteinuria
Official Title
The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Proteinuria
Keywords
proteinuria, chronic kidney disease, renin-angiotensin system, angiotensinogen

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
valsartan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
valsartan
Intervention Description
160 mg oral once in a day for initial 8 weeks and 320 mg, oral, once in a day for subsequent 16 weeks
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon-Goo Kim, Professor
Phone
82-2-3410-3442
Email
ygkim26@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-Goo Kim, Professor
Organizational Affiliation
Division of Nephrology, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Nephrology, Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon-Goo Kim, Professor

12. IPD Sharing Statement

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

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