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

September 11, 2005
March 20, 2009
February 2003
April 2008   (final data collection date for primary outcome measure)
Course of renal and cardiac function [ Time Frame: every month for renal function and every year for cardiac function ] [ Designated as safety issue: Yes ]
Course of renal and cardiac function
Complete list of historical versions of study NCT00190580 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Hypertension
  • Drug: valsartan
    valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
    Other Name: 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 Name: any antihypertensive drug except ARB
  • Experimental: 1
    Intervention: Drug: valsartan
  • No Intervention: 2
    Intervention: Drug: Conventional antihypertensive drugs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00190580
620
Yes
Kenjiro Kimura / Professor of Medicine, St. Marianna University School of Medicine
KVT-Study Group
  • Tokai University
  • Yokohama City University Medical Center
  • Showa University
  • Kitasato University
  • St. Marianna University School of Medicine
Study Chair: Kenjiro Kimura, MD, PhD St. Marianna University School of Medicine
KVT-Study Group
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP