Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Samsung Medical Center Identifier:
First received: March 5, 2009
Last updated: March 6, 2009
Last verified: March 2009

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.

Condition Intervention Phase
Chronic Kidney Disease
Drug: valsartan
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: valsartan 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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00858299

Contact: Yoon-Goo Kim, Professor 82-2-3410-3442

Korea, Republic of
Division of Nephrology, Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Principal Investigator: Yoon-Goo Kim, Professor         
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Yoon-Goo Kim, Professor Division of Nephrology, Samsung Medical Center
  More Information

Responsible Party: Yoon-Goo Kim, Division of Nephrology, Samsung Medical Center Identifier: NCT00858299     History of Changes
Other Study ID Numbers: 2008-07-089
Study First Received: March 5, 2009
Last Updated: March 6, 2009

Keywords provided by Samsung Medical Center:
chronic kidney disease
renin-angiotensin system

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Angiotensin II
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Vasoconstrictor Agents processed this record on May 25, 2017