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

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ClinicalTrials.gov Identifier: NCT00858299
Recruitment Status : Unknown
Verified March 2009 by Samsung Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 9, 2009
Last Update Posted : March 9, 2009
Sponsor:
Information provided by:
Samsung Medical Center

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Proteinuria Drug: valsartan Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria
Study Start Date : March 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858299


Contacts
Contact: Yoon-Goo Kim, Professor 82-2-3410-3442 ygkim26@skku.edu

Locations
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
Investigators
Principal Investigator: Yoon-Goo Kim, Professor Division of Nephrology, Samsung Medical Center

Responsible Party: Yoon-Goo Kim, Division of Nephrology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00858299     History of Changes
Other Study ID Numbers: 2008-07-089
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Proteinuria
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
Signs and Symptoms
Valsartan
Angiotensinogen
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