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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00858299
• Other study ID #: 2008-07-089
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 5, 2009
• Last updated: March 6, 2009
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2009
• Source: Samsung Medical Center
• Contact: Yoon-Goo Kim, Professor
• Phone: 82-2-3410-3442
• Email: ygkim26[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Division of Nephrology, Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No