The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Patients With Persistent Proteinuria
Information source: Samsung Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease; Proteinuria
Intervention: valsartan (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s):
Yoon-Goo Kim, Professor, Principal Investigator, Affiliation: Division of Nephrology, Samsung Medical Center
Overall contact:
Yoon-Goo Kim, Professor, Phone: 82-2-3410-3442, Email: ygkim26@skku.edu
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.
Clinical Details
Official title: The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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)
Locations and Contacts
Yoon-Goo Kim, Professor, Phone: 82-2-3410-3442, Email: ygkim26@skku.edu
Division of Nephrology, Samsung Medical Center, Seoul 135-710, Korea, Republic of; Not yet recruiting
Yoon-Goo Kim, Professor, Principal Investigator
Additional Information
Starting date: March 2009
Last updated: March 6, 2009
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