Chronic Kidney DiseasePhase 4NCT00190580
Kanagawa Valsartan Trial (KVT): Effects of Valsartan on Renal and Cardiovascular Disease
A Phase 4 study testing valsartan and Conventional antihypertensive drugs in people with Chronic Kidney Disease and Hypertension, run by KVT-Study Group at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- valsartan and Conventional antihypertensive drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2003to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD with serum creatinine more than 2.0 mg/dl
- Blood pressure more than 130/85 mmHg
- 20 years old or above
Who cannot join
- End-stage renal disease with maintenance dialysis
- Polycystic kidney disease
- Collagen disease
- Malignant or accelerated hypertension
Trial locations and contacts
1 site in 1 country.
Japan1 site
St. Marianna University School of Medicine
Kawasaki, Kanagawa, 216-8511
About this study
Official title: 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.
Read the 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
- Being tested
- valsartan, Conventional antihypertensive drugs
- Keywords
- CKD, chronic kidney disease, hypertension, angiotensin II receptor blocker, cardiovascular disease, valsartan, KVT
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
Also called Diovan 40mg or Diovan 80mg
valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
Conventional antihypertensive drugsDrug
Also called any antihypertensive drug except ARB
Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: valsartan; Drug: Conventional antihypertensive drugs |
| 2 | Experimental | Not described Receives: Drug: Conventional antihypertensive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of renal and cardiac function
Measured: every month for renal function and every year for cardiac function
Secondary outcomes (8)
Doubling of serum creatinine concentration
Measured: every month
End-stage renal disease
Measured: anytime when it occurs.
Myocardial infarction
Measured: anytime when it occurs.
Coronary revascularization
Measured: anytime when it occurs.
Stroke
Measured: anytime when it occurs
Hospitalization for unstable angina
Measured: anytime when it occurs.
Hospitalization for heart failure
Measured: anytime when it occurs.
Death from cardiovascular causes
Measured: anytime when it occurs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- KVT-Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Tokai University, Yokohama City University, Showa University, Kitasato University, St. Marianna University School of Medicine
- Responsible party
- Principal investigator, Kenjiro Kimura, KVT-Study Group
- Investigators
- Kenjiro Kimura, MD, PhD, Study chair, St. Marianna University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190580
- Sponsor's protocol ID
- 620
- Status last verified
- Mar 2009
- First submitted
- 11 Sep 2005
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Valsartan on the Progression of Renal and Cardiovascular Disease - Kanagawa Valsartan Trial (KVT)
- ClinicalTrials.gov ID
- NCT00190580
- Acronym / sponsor ID
- 620
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- CKD, chronic kidney disease, hypertension, angiotensin II receptor blocker, cardiovascular disease, valsartan, KVT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- KVT-Study GroupUniversity, hospital or other
- Collaborators
- Tokai University, Yokohama City University, Showa University, Kitasato University, St. Marianna University School of Medicine
- Study start
- Feb 2003
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: valsartan, Drug: Conventional antihypertensive drugs |
| 2 | Experimental | Drug: Conventional antihypertensive drugs |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD with serum creatinine more than 2.0 mg/dl
- Blood pressure more than 130/85 mmHg
- 20 years old or above
Key exclusion criteria (4 listed)
- End-stage renal disease with maintenance dialysis
- Polycystic kidney disease
- Collagen disease
- Malignant or accelerated hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valsartanAlso: Diovan 40mg or Diovan 80mgvalsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs | Drug | 1 |
| Conventional antihypertensive drugsAlso: any antihypertensive drug except ARBConventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers | Drug | 1, 2 |
Primary outcome
Course of renal and cardiac function
Time frame: every month for renal function and every year for cardiac function
8 secondary outcomes
Doubling of serum creatinine concentration
Time frame: every month
End-stage renal disease
Time frame: anytime when it occurs.
Myocardial infarction
Time frame: anytime when it occurs.
Coronary revascularization
Time frame: anytime when it occurs.
Stroke
Time frame: anytime when it occurs
Hospitalization for unstable angina
Time frame: anytime when it occurs.
Hospitalization for heart failure
Time frame: anytime when it occurs.
Death from cardiovascular causes
Time frame: anytime when it occurs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenjiro Kimura, MD, PhD study chair
St. Marianna University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan and Conventional antihypertensive drugs in people with Chronic Kidney Disease and Hypertension, run by KVT-Study Group at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of renal and cardiac function (time frame: every month for renal function and every year for cardiac function). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.