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

Primary Purpose

Chronic Kidney Disease, Hypertension

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
valsartan
Conventional antihypertensive drugs
Sponsored by
KVT-Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD, chronic kidney disease, hypertension, angiotensin II receptor blocker, cardiovascular disease, valsartan, KVT

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Marianna University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Course of renal and cardiac function

Secondary Outcome Measures

Doubling of serum creatinine concentration
End-stage renal disease
Myocardial infarction
Coronary revascularization
Stroke
Hospitalization for unstable angina
Hospitalization for heart failure
Death from cardiovascular causes

Full Information

First Posted
September 11, 2005
Last Updated
March 30, 2015
Sponsor
KVT-Study Group
Collaborators
Tokai University, Yokohama City University, Showa University, Kitasato University, St. Marianna University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00190580
Brief Title
Kanagawa Valsartan Trial (KVT): Effects of Valsartan on Renal and Cardiovascular Disease
Official Title
Effects of Valsartan on the Progression of Renal and Cardiovascular Disease - Kanagawa Valsartan Trial (KVT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KVT-Study Group
Collaborators
Tokai University, Yokohama City University, Showa University, Kitasato University, St. Marianna University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension
Keywords
CKD, chronic kidney disease, hypertension, angiotensin II receptor blocker, cardiovascular disease, valsartan, KVT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
valsartan
Other Intervention Name(s)
Diovan 40mg or Diovan 80mg
Intervention Description
valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
Intervention Type
Drug
Intervention Name(s)
Conventional antihypertensive drugs
Other Intervention Name(s)
any antihypertensive drug except ARB
Intervention Description
Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
Primary Outcome Measure Information:
Title
Course of renal and cardiac function
Time Frame
every month for renal function and every year for cardiac function
Secondary Outcome Measure Information:
Title
Doubling of serum creatinine concentration
Time Frame
every month
Title
End-stage renal disease
Time Frame
anytime when it occurs.
Title
Myocardial infarction
Time Frame
anytime when it occurs.
Title
Coronary revascularization
Time Frame
anytime when it occurs.
Title
Stroke
Time Frame
anytime when it occurs
Title
Hospitalization for unstable angina
Time Frame
anytime when it occurs.
Title
Hospitalization for heart failure
Time Frame
anytime when it occurs.
Title
Death from cardiovascular causes
Time Frame
anytime when it occurs.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenjiro Kimura, MD, PhD
Organizational Affiliation
St. Marianna University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
St. Marianna University School of Medicine
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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