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

This study is not yet open for participant recruitment.

Verified by Samsung Medical Center, March 2009

First Received: March 5, 2009 Last Updated: March 6, 2009 History of Changes

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00858299

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 IV

Drug Information available for: Valsartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria

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
valsartan: Experimental	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

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
Seoul, Korea, Republic of, 135-710

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:	Division of Nephrology, Samsung Medical Center ( Yoon-Goo Kim )
Study ID Numbers:	2008-07-089
Study First Received:	March 5, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00858299 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:

proteinuria
chronic kidney disease
renin-angiotensin system
angiotensinogen

Study placed in the following topic categories:

Serine Proteinase Inhibitors
Renal Insufficiency
Urination Disorders
Kidney Failure, Chronic
Cardiovascular Agents
Angiotensinogen
Antihypertensive Agents
Protease Inhibitors

Signs and Symptoms
Proteinuria
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Valsartan
Kidney Failure

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Kidney Failure, Chronic
Enzyme Inhibitors
Cardiovascular Agents
Angiotensinogen
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Kidney Diseases
Valsartan
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009