Chronic Kidney DiseaseNCT02078115
Assessment of Blood Pressure Control and Target Organ Damage in Patients With Chronic Kidney Disease and Hypertension -II
An observational study of Chronic Kidney Disease and Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to find the change of blood pressure (BP) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3 years. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Jul 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic kidney disease patients with hypertension
Who may be able to join
- with informed consent
- 20 <= age < 75 years
- diagnosed as hypertension 6 months (or 3 visits) prior to enrollment, taking anti-hypertensive drugs over 3 months
- all-cause chronic kidney disease patients with 15 <= estimated GFR < 90
- no change of anti-hypertensive drugs within 2 weeks and good compliance
Who cannot join
- changed prescription according to ambulatory blood pressure monitoring (ABPM) regularly
- had acute kidney injury/hospitalization
- had a proteinuria of > 6 g/day (spot urine protein to creatinine ratio > 6.0 g/g Cr)
- had end stage renal disease (ESRD) with dialysis and/or were a kidney recipient
- had diseases, such as uncontrolled arrhythmia, uncontrolled bronchial asthma/chronic obstructive pulmonary disease, or primary endocrinologic diseases except diabetes mellitus
- were pregnant/lactating women
- were night shift workers.
Trial locations and contacts
1 site in 1 country.
Sung Kyun Kim, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Ran-hui Cha, MD, reginaprayer@gmail.com
Hajeong Lee, MD
About this study
Official title: Observational Study of Blood Pressure Control Pattern and the Impact on the Target Organ Damages
The purpose of this study is to find the change of blood pressure (BP) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3 years. And Other objective is the relationship between the BP control pattern and the target organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so on. In addition, we will find clinical factors related to the BP control pattern.
- Conditions
- Chronic Kidney Disease, Hypertension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic kidney disease, hypertension | 20 <= age < 75 years 15 <= estimated glomerular filtration rate (GFR) < 90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of blood pressure control pattern in patients with CKD
Measured: 1 year after enrolling the last participant
Secondary outcomes (3)
1) target organ damages in kidney and heart
Measured: 1 year after enrolling the last participant
2) the relationship between the change of BP control pattern and the target organ damages
Measured: 1 year after enrolling the last participant
3) assessment of related clinical factors with BP control pattern
Measured: 1 year after enrolling the last participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startApr 2013
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Su Kim, Seoul National University Hospital
- Investigators
- Sung Kyun Kim, MD, Study director, Hallym University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078115
- Sponsor's protocol ID
- APRODITE-2
- Other IDs
- Boryung
- Status last verified
- Mar 2014
- First submitted
- 5 Feb 2014
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Blood Pressure Control Pattern and the Impact on the Target Organ Damages
- ClinicalTrials.gov ID
- NCT02078115
- Acronym / sponsor ID
- APRODITE-2
- Conditions
- Chronic Kidney Disease, Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 5 Mar 2014 (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 find the change of blood pressure (BP) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3 years. And Other objective is the relationship between the BP control pattern and the target organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so on. In addition, we will find clinical factors related to the BP control pattern.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic kidney disease, hypertension | – | –20 <= age < 75 years 15 <= estimated glomerular filtration rate (GFR) < 90 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic kidney disease patients with hypertension
Key inclusion criteria (5 listed)
- with informed consent
- 20 <= age < 75 years
- diagnosed as hypertension 6 months (or 3 visits) prior to enrollment, taking anti-hypertensive drugs over 3 months
- all-cause chronic kidney disease patients with 15 <= estimated GFR < 90
- no change of anti-hypertensive drugs within 2 weeks and good compliance
Key exclusion criteria (7 listed)
- changed prescription according to ambulatory blood pressure monitoring (ABPM) regularly
- had acute kidney injury/hospitalization
- had a proteinuria of > 6 g/day (spot urine protein to creatinine ratio > 6.0 g/g Cr)
- had end stage renal disease (ESRD) with dialysis and/or were a kidney recipient
- had diseases, such as uncontrolled arrhythmia, uncontrolled bronchial asthma/chronic obstructive pulmonary disease, or primary endocrinologic diseases except diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of blood pressure control pattern in patients with CKD
Time frame: 1 year after enrolling the last participant
3 secondary outcomes
1) target organ damages in kidney and heart
Time frame: 1 year after enrolling the last participant
2) the relationship between the change of BP control pattern and the target organ damages
Time frame: 1 year after enrolling the last participant
3) assessment of related clinical factors with BP control pattern
Time frame: 1 year after enrolling the last participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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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.
Sung Kyun Kim, MD contact
Sung Kyun Kim, MD study director
Hallym University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Hypertension, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Mar 2014. 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 South Korea. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Kyun Kim, MD (imnksk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of blood pressure control pattern in patients with CKD (time frame: 1 year after enrolling the last participant). 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 5 Mar 2014.