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

This study has been completed.
Sponsor:
Collaborators:
Tokai University
Yokohama City University Medical Center
Showa University
Kitasato University
St. Marianna University School of Medicine
Information provided by:
KVT-Study Group
ClinicalTrials.gov Identifier:
NCT00190580
First received: September 11, 2005
Last updated: March 20, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Hypertension
 Drug: valsartan
Drug: Conventional antihypertensive drugs
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Valsartan on the Progression of Renal and Cardiovascular Disease - Kanagawa Valsartan Trial (KVT)

Resource links provided by NLM:

Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by KVT-Study Group:

Primary Outcome Measures:
  • Course of renal and cardiac function [ Time Frame: every month for renal function and every year for cardiac function ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Doubling of serum creatinine concentration [ Time Frame: every month ] [ Designated as safety issue: Yes ]
  • End-stage renal disease [ Time Frame: anytime when it occurs. ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: anytime when it occurs. ] [ Designated as safety issue: Yes ]
  • Coronary revascularization [ Time Frame: anytime when it occurs. ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: anytime when it occurs ] [ Designated as safety issue: Yes ]
  • Hospitalization for unstable angina [ Time Frame: anytime when it occurs. ] [ Designated as safety issue: Yes ]
  • Hospitalization for heart failure [ Time Frame: anytime when it occurs. ] [ Designated as safety issue: Yes ]
  • Death from cardiovascular causes [ Time Frame: anytime when it occurs. ] [ Designated as safety issue: Yes ]

Enrollment: 312
Study Start Date: February 2003
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: valsartan
valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
Other Name: Diovan 40mg or Diovan 80mg
No Intervention: 2 Drug: Conventional antihypertensive drugs
Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
Other Name: any antihypertensive drug except ARB

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190580

Locations
Japan
St. Marianna University School of Medicine
Kawasaki, Kanagawa, Japan, 216-8511
Sponsors and Collaborators
KVT-Study Group
Tokai University
Yokohama City University Medical Center
Showa University
Kitasato University
St. Marianna University School of Medicine
Investigators
Study Chair: Kenjiro Kimura, MD, PhD St. Marianna University School of Medicine
  More Information

No publications provided

Responsible Party: Kenjiro Kimura / Professor of Medicine, St. Marianna University School of Medicine
ClinicalTrials.gov Identifier: NCT00190580     History of Changes
Other Study ID Numbers: 620
Study First Received: September 11, 2005
Last Updated: March 20, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by KVT-Study Group:
CKD
chronic kidney disease
hypertension
angiotensin II receptor blocker
 cardiovascular disease
valsartan
KVT

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Vascular Diseases
Urologic Diseases
Renal Insufficiency
Angiotensin-Converting Enzyme Inhibitors
Valsartan
 Antihypertensive Agents
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on May 19, 2013