Chronic Kidney Disease, Proteinuria
Conditions
Keywords
proteinuria, chronic kidney disease, renin-angiotensin system, angiotensinogen
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.
Interventions
DRUGvalsartan
160 mg oral once in a day for initial 8 weeks and 320 mg, oral, once in a day for subsequent 16 weeks
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactYoon-Goo Kim, Professor
Outcome results
None listed