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

NCT00858299 | Unknown Phase 4 DMC

• 1 other identifier: 2008-07-089
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Proteinuria

Keywords

proteinuria; chronic kidney disease; renin-angiotensin system; angiotensinogen

Outcome Measures

Primary Outcomes (1)

• The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.

  4 weeks of screening periods + 24 weeks of treatment

Study Arms (1)

valsartan

EXPERIMENTAL

Drug: valsartan

Interventions

valsartan DRUG

160 mg oral once in a day for initial 8 weeks and 320 mg, oral, once in a day for subsequent 16 weeks

valsartan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Division of Nephrology, Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Yoon-Goo Kim, Professor

  Division of Nephrology, Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoon-Goo Kim, Professor

CONTACT

82-2-3410-3442; ygkim26@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 9, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 9, 2009

Record last verified: 2009-03

Locations

KR (1)