Kanagawa Valsartan Trial (KVT): Effects of Valsartan on Renal and Cardiovascular Disease

Effects of Valsartan on the Progression of Renal and Cardiovascular Disease - Kanagawa Valsartan Trial (KVT)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190580

Enrollment

312

Registered

2005-09-19

Start date

2003-02-28

Completion date

2008-04-30

Last updated

2015-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Hypertension

Keywords

CKD, chronic kidney disease, hypertension, angiotensin II receptor blocker, cardiovascular disease, valsartan, KVT

Brief summary

The purpose of this study is to prove the hypothesis that the progression of renal and cardiovascular disease is more efficiently prevented when the angiotensin II receptor blocker valsartan is added to conventional antihypertensive therapy.

Detailed description

It is widely recognized that suppression of the renin-angiotensin system ameliorates progression of chronic kidney disease (CKD) and that CKD is an important risk factor for development of cardiovascular disease. However, it has not been fully clarified if amelioration of CKD leads to the lower incidence of cardiovascular disease. The purpose of this study is to determine whether the angiotensin II receptor antagonist valsartan, in combination with conventional antihypertensive therapy, will ameliorate progression of both CKD and cardiovascular disease. The primary outcome is courses of renal and cardiac function. The secondary outcome is a composite of a doubling of serum creatinine concentration, end-stage renal disease, myocardial infarction, coronary revascularization, stroke, hospitalization for unstable angina, hospitalization for heart failure or death from cardiovascular causes.

Interventions

DRUGvalsartan

valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs

DRUGConventional antihypertensive drugs

Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* CKD with serum creatinine more than 2.0 mg/dl * Blood pressure more than 130/85 mmHg * 20 years old or above

Exclusion criteria

* End-stage renal disease with maintenance dialysis * Polycystic kidney disease * Collagen disease * Malignant or accelerated hypertension

Design outcomes

Primary

Measure	Time frame
Course of renal and cardiac function	every month for renal function and every year for cardiac function

Secondary

Measure	Time frame
End-stage renal disease	anytime when it occurs.
Myocardial infarction	anytime when it occurs.
Coronary revascularization	anytime when it occurs.
Doubling of serum creatinine concentration	every month
Hospitalization for unstable angina	anytime when it occurs.
Hospitalization for heart failure	anytime when it occurs.
Death from cardiovascular causes	anytime when it occurs.
Stroke	anytime when it occurs

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026