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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Samsung Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00858299
First received: March 5, 2009
Last updated: March 6, 2009
Last verified: March 2009
  Purpose

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
Proteinuria
Drug: valsartan
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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)
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 5, 2009
Last Updated: March 6, 2009
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Proteinuria
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Renal Insufficiency
Valsartan
Angiotensinogen
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014