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

March 30, 2015 updated by: Kenjiro Kimura, KVT-Study Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: valsartan
valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
Other Names:
  • Diovan 40mg or Diovan 80mg
Drug: Conventional antihypertensive drugs
Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
Other Names:
  • any antihypertensive drug except ARB
EXPERIMENTAL: 2
Drug: Conventional antihypertensive drugs
Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
Other Names:
  • any antihypertensive drug except ARB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Course of renal and cardiac function
Time Frame: every month for renal function and every year for cardiac function
every month for renal function and every year for cardiac function

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KVT-Study Group

Collaborators

Yokohama City University
Showa University
Kitasato University
St. Marianna University School of Medicine
Tokai University

Investigators

  • Study Chair: Kenjiro Kimura, MD, PhD, St. Marianna University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (ESTIMATE)

September 19, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 620 (GCRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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