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

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
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

Page last updated: August 20, 2015

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