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

NCT ID: NCT00190580

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2008-04-30

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.

Conditions

Chronic Kidney Disease; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

valsartan

Intervention Type: DRUG

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

Conventional antihypertensive drugs

Intervention Type: DRUG

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

2

Group Type: EXPERIMENTAL

Conventional antihypertensive drugs

Intervention Type: DRUG

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

Interventions

valsartan

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

Intervention Type: DRUG

Conventional antihypertensive drugs

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

Intervention Type: DRUG

Other Intervention Names

Diovan 40mg or Diovan 80mg; any antihypertensive drug except ARB

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokai University

OTHER

Sponsor Role: collaborator

Yokohama City University

OTHER

Sponsor Role: collaborator

Showa University

OTHER

Sponsor Role: collaborator

Kitasato University

OTHER

Sponsor Role: collaborator

St. Marianna University School of Medicine

OTHER

Sponsor Role: collaborator

KVT-Study Group

OTHER

Sponsor Role: lead

Responsible Party

Kenjiro Kimura

Professor of St. Marianna University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenjiro Kimura, MD, PhD

Role: STUDY_CHAIR

St. Marianna University School of Medicine

Locations

St. Marianna University School of Medicine

Kawasaki, Kanagawa, Japan

Countries

Japan

Other Identifiers

620

Identifier Type: -

Identifier Source: org_study_id