Arterial HypertensionPhase 2KPSNCT02002585
Renal Protection Using Sympathetic Denervation in Patients With Chronic Kidney Disease
A Phase 2 study testing Renal denervation in people with Arterial Hypertension and Chronic Renal Insufficiency, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Hypertension, Chronic Renal Insufficiency
- What is being tested?
- Renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- Nov 2013to Dec 2018
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age between 18-80 years
- Chronic renal insufficiency in CKD 3-4 from nephrologist (eGFR (MDRD) ≤ 45 ml/min/1.73 m2)
- Arterial hypertension treated with:
- systolic BP ≥ 140 mmHg + at least 3 antihypertensive drugs Including a diuretic systolic BP ≥ 135 mmHg + 3 antihypertensives Including a diuretics + diabetes mellitus type 2.
- systolic BP ≥ 130 mmHg on 24 hr ABPM + 3 antihypertensive drugs Including a diuretics
- Renal artery diameter ≥ 4 mm according to the renal angiography (documented on quantitative renal angiography), renal artery length at least 20mm
Who cannot join
- Secondary hypertension
- White coat hypertension
- abnormalities in renal angiogram disqualifying for RDN
- Life expectancy < 1 year
- Type 1. Diabetes mellitus
- Significant stenotic valvular heart disease
- Acute coronary syndrome of unstable angina in the past 6 months
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Charles University in Prague
Prague, 12808
Jean Claude Lubanda, Ass.Prof.MD, +420224962692, Jean-Claude.Lubanda@vfn.cz
Martina Striteska, Mgr., +224962605, Martina.Striteska@vfn.cz
About this study
Official title: Renal Protection Using Sympathetic Denervation in Patients With Chronic Kidney Disease (Kidney Protection Study - KPS Study)
Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone. Renal denervation is a modern endovascular method used to treat resistant hypertension. The method is being extended to other groups of patients, where the sympathetic tone is increased beyond resistant hypertension. Because of the character of the disease, we hypothesize that renal denervation can reduce or prevent progressive deterioration of kidney functions in this patient population. The aim of this clinical study is to show that renal denervation has protective effects on the progression of chronic renal insufficiency.
Read the detailed description
Background:
patients with chronic renal insufficiency are an ideal group for renal denervation (RDN), because of the increase in sympathetic tone. This increase leads to sodium retention, reduction of perfusion of the kidney and to excessive activation of renin angiotensin aldosterone system. The activation of the sympathetic system significantly contributes to the progression of chronic renal insufficiency. The consequences the hyperactivity of the sympathetic system are affected by selective renal sympathectomy. RDN demonstrably reduces retention of sodium, reduces the production of renin and significantly reduces renal vascular resistance. Furthermore, RDN reduces microalbuminuria and renal podocyte damage in experimental model. RDN also improves renal function in the model of acute Glomerulonephritis. In patients with resistant hypertension and preserved renal function, it was also shown that renal denervation improves renal resistant index and significantly decreases microalbuminuria. The procedure was found to be safe in all studies with renal denervation and was not associated with deterioration of renal function. Several experimental data exist on the effectiveness of RDN in chronic renal insufficiency. In a model of acute renal failure in mouse (endotoxemia model), it was shown that RDN has protective effect on renal function. The decline in the glomerular filtration during endotoxemia was significantly lower in the group treated with RDN compared to the control group. In addition, the renal flow during acute renal failure after RDN was improved. In the model of heart failure in mice, it has been shown that RDN in combination with olmesartan reduces albuminuria and the damage of podocytes and also reduces the levels of renal norepinephrine, angiotensinogen, angiotensin II, and the level of oxidative stress.
Very few data on the effect of RDN on renal function in human were also published. Renal damage in hypertensives subject was not found after RDN with the Symplicity system more than 3 years post procedure. Mahfoud and coworkers showed that subject treated with RDN had lower blood pressure and renal resistive index and at the same time stabilize their renal function. The number of patients with microalbuminuria or macroalbuminuria decreased significantly one year after RDN.
RDN has also positive effect on albuminuria and proteinuria in patients with preserved renal function. The first studies performed in patients with chronic kidney disease (CKD stage 3-4) and resistant hypertension was done by Hering et coworkers. In this study, 15 patients with an average eGFR of 31ml/min/1, 73m2 underwent RDN. The authors were able to show that RDN effectively lowers blood pressure and was not associated further deterioration of renal function. RDN had other positive effects on hemoglobin concentration , proteinuria and on BNP levels. Moreover, the augmentation index of peripheral arteries was also improved by RDN. This work showed multiple effects of RDN beyond the reduction of blood pressure. We, therefore think that patient with chronic kidney disease are good candidates for RDN. However, the mentioned study has a relatively short term follow up (6 months to one year) and does not have a comparative arm.
Aim of study :
our proposed trial aimed to show that RDN not only contribute to improve the control of blood pressure in patients with resistant hypertension but also has protective effects on kidney function in subjects with chronic kidney disease. Our trial will have a comparative arm and will last 3 years.
Planned intervention:
The two strategies that are going to be compared are optimal medical therapy against optimal medical therapy with renal denervation.
- Conditions
- Arterial Hypertension, Chronic Renal Insufficiency
- Being tested
- Renal denervation
- Keywords
- Renal protection, Renal sympathetic denervation
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationProcedure or surgery
Also called RDN - Renal sympathetic denervation
Catheter based renal sympathetic denervation is a endovascular method used for the treatment of resistent hypertension.
| Study group | Role | What they receive |
|---|---|---|
| RDN and optimal medical therapy | Experimental | Renal denervation will be performed using the available denervation device with a european approval according to current guidelines. The same device will be used for all patients in this arm to avoid efficacy bias. Receives: Procedure: Renal denervation |
| optimal medical therapy alone | No intervention | Group of patients who will be treated only with optimal medical therapy and will not be denervated. Subsequently, the patients will be followed in our cardiology and nephrology department according to the study flowchart for 3 years according to the standard of care in our institution for patients with chronic renal insufficiency. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of eGFR by MDRD
The changes of the value of eGFR measured using the MDRD equation in both groups measure at baseline and after 6 months
Measured: 6 months
Changes in proteinuria (Microalbuminuria) in 6 months
the change in the value of proteinuria expressed in g/24hrs or microalbuminuria expressed in ug/24hrs measured at baseline compared to value at 6 month in both study groups
Measured: 6 months
Changes in the value of Cystatin C
Changes in the value of Cystatin C measure at baseline and after 6 months in both groups
Measured: 6 months
Time to the development of end-stage renal disease (ESRD)/Hemodialysis
The time to the development of end-stage renal disease (ESRD)/Hemodialysis in both groups
Measured: 3 years
combined renal endpoint
the combination of all primary outcomes measured compared to baseline in both groups
Measured: 6 months
Secondary outcomes (8)
Total mortality
the total mortality in both groups at 6 months, 2 years and 3 years
Measured: 3 years
The total cardiovascular mortality
the total cardiovascular mortality in 6 months, 2 years and 3 years in both groups
Measured: 3 years
total renal mortality
the total renal mortality in both arms at 6 months, 2 years and 3 years
Measured: 3 years
changes in blood pressure
the changes of systolic and diastolic blood pressure at 6 months, 1, 2 and 3 years measured as office blood pressure, home blood pressure monitoring and ambulatory blood pressure monitoring (ABPM) from baseline in both arms
Measured: 3 years
•Changes in concentration of Blood urea Nitrogen (BUN) , creatinine in 6 months, 3 years
the changes in concentration of blood urea Nitrogen (BUN) and creatinine in 6 months, 1, 2 and 3 years in both arms
Measured: 3 years
albumin-creatine ratio
Albumin-Creatinine-Ratio (mg/mmol) in 6 months, 1, 2 and 3 years in both arms
Measured: 3 years
changes in cardiac structure and function
the changes in cardiac structure and function assessed by echocardiography (left ventricular mass, left ventricular ejection fraction, left ventricular diastolic function) at 6 months, 1, 2 and 3 years in both arms.
Measured: 3 years
the changes in renal resistive index
•the changes in renal resistive index (RRI) measured using renal duplex ultrasound at 6 months, 1, 2 and 3 years in both groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague, Na Homolce Hospital, Mount Sinai Hospital, New York
- Responsible party
- Principal investigator, Ass. prof. Jean-Claude M. Lubanda, MD, Ph.D, Charles University, Czech Republic
- Investigators
- Jean Claude Lubanda, Ass.Prof. MD, Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002585
- Sponsor's protocol ID
- KPS1
- Acronym
- KPS
- Status last verified
- Dec 2013
- First submitted
- 25 Nov 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Protection Using Sympathetic Denervation in Patients With Chronic Kidney Disease (Kidney Protection Study - KPS Study)
- ClinicalTrials.gov ID
- NCT02002585
- Acronym / sponsor ID
- KPS / KPS1
- Conditions
- Arterial Hypertension, Chronic Renal Insufficiency
- Keywords
- Renal protection, Renal sympathetic denervation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague, Na Homolce Hospital, Mount Sinai Hospital, New York
- Study start
- Nov 2013
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Dec 2013 (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.
Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone. Renal denervation is a modern endovascular method used to treat resistant hypertension. The method is being extended to other groups of patients, where the sympathetic tone is increased beyond resistant hypertension. Because of the character of the disease, we hypothesize that renal denervation can reduce or prevent progressive deterioration of kidney functions in this patient population. The aim of this clinical study is to show that renal denervation has protective effects on the progression of chronic renal insufficiency.
Detailed description
Background:
patients with chronic renal insufficiency are an ideal group for renal denervation (RDN), because of the increase in sympathetic tone. This increase leads to sodium retention, reduction of perfusion of the kidney and to excessive activation of renin angiotensin aldosterone system. The activation of the sympathetic system significantly contributes to the progression of chronic renal insufficiency. The consequences the hyperactivity of the sympathetic system are affected by selective renal sympathectomy. RDN demonstrably reduces retention of sodium, reduces the production of renin and significantly reduces renal vascular resistance. Furthermore, RDN reduces microalbuminuria and renal podocyte damage in experimental model. RDN also improves renal function in the model of acute Glomerulonephritis. In patients with resistant hypertension and preserved renal function, it was also shown that renal denervation improves renal resistant index and significantly decreases microalbuminuria. The procedure was found to be safe in all studies with renal denervation and was not associated with deterioration of renal function. Several experimental data exist on the effectiveness of RDN in chronic renal insufficiency. In a model of acute renal failure in mouse (endotoxemia model), it was shown that RDN has protective effect on renal function. The decline in the glomerular filtration during endotoxemia was significantly lower in the group treated with RDN compared to the control group. In addition, the renal flow during acute renal failure after RDN was improved. In the model of heart failure in mice, it has been shown that RDN in combination with olmesartan reduces albuminuria and the damage of podocytes and also reduces the levels of renal norepinephrine, angiotensinogen, angiotensin II, and the level of oxidative stress.
Very few data on the effect of RDN on renal function in human were also published. Renal damage in hypertensives subject was not found after RDN with the Symplicity system more than 3 years post procedure. Mahfoud and coworkers showed that subject treated with RDN had lower blood pressure and renal resistive index and at the same time stabilize their renal function. The number of patients with microalbuminuria or macroalbuminuria decreased significantly one year after RDN.
RDN has also positive effect on albuminuria and proteinuria in patients with preserved renal function. The first studies performed in patients with chronic kidney disease (CKD stage 3-4) and resistant hypertension was done by Hering et coworkers. In this study, 15 patients with an average eGFR of 31ml/min/1, 73m2 underwent RDN. The authors were able to show that RDN effectively lowers blood pressure and was not associated further deterioration of renal function. RDN had other positive effects on hemoglobin concentration , proteinuria and on BNP levels. Moreover, the augmentation index of peripheral arteries was also improved by RDN. This work showed multiple effects of RDN beyond the reduction of blood pressure. We, therefore think that patient with chronic kidney disease are good candidates for RDN. However, the mentioned study has a relatively short term follow up (6 months to one year) and does not have a comparative arm.
Aim of study :
our proposed trial aimed to show that RDN not only contribute to improve the control of blood pressure in patients with resistant hypertension but also has protective effects on kidney function in subjects with chronic kidney disease. Our trial will have a comparative arm and will last 3 years.
Planned intervention:
The two strategies that are going to be compared are optimal medical therapy against optimal medical therapy with renal denervation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDN and optimal medical therapy | Experimental | Procedure: Renal denervationRenal denervation will be performed using the available denervation device with a european approval according to current guidelines. The same device will be used for all patients in this arm to avoid efficacy bias. |
| optimal medical therapy alone | No intervention | –Group of patients who will be treated only with optimal medical therapy and will not be denervated. Subsequently, the patients will be followed in our cardiology and nephrology department according to the study flowchart for 3 years according to the standard of care in our institution for patients with chronic renal insufficiency. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Age between 18-80 years
- Chronic renal insufficiency in CKD 3-4 from nephrologist (eGFR (MDRD) ≤ 45 ml/min/1.73 m2)
- Arterial hypertension treated with:
- systolic BP ≥ 140 mmHg + at least 3 antihypertensive drugs Including a diuretic systolic BP ≥ 135 mmHg + 3 antihypertensives Including a diuretics + diabetes mellitus type 2.
Key exclusion criteria (7 listed)
- Secondary hypertension
- White coat hypertension
- abnormalities in renal angiogram disqualifying for RDN
- Life expectancy < 1 year
- Type 1. 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal denervationAlso: RDN - Renal sympathetic denervationCatheter based renal sympathetic denervation is a endovascular method used for the treatment of resistent hypertension. | Procedure or surgery | RDN and optimal medical therapy |
Primary outcome
The changes of eGFR by MDRD
Time frame: 6 months
The changes of the value of eGFR measured using the MDRD equation in both groups measure at baseline and after 6 months
Changes in proteinuria (Microalbuminuria) in 6 months
Time frame: 6 months
the change in the value of proteinuria expressed in g/24hrs or microalbuminuria expressed in ug/24hrs measured at baseline compared to value at 6 month in both study groups
Changes in the value of Cystatin C
Time frame: 6 months
Changes in the value of Cystatin C measure at baseline and after 6 months in both groups
Time to the development of end-stage renal disease (ESRD)/Hemodialysis
Time frame: 3 years
The time to the development of end-stage renal disease (ESRD)/Hemodialysis in both groups
combined renal endpoint
Time frame: 6 months
the combination of all primary outcomes measured compared to baseline in both groups
8 secondary outcomes
Total mortality
Time frame: 3 years
The total cardiovascular mortality
Time frame: 3 years
total renal mortality
Time frame: 3 years
changes in blood pressure
Time frame: 3 years
•Changes in concentration of Blood urea Nitrogen (BUN) , creatinine in 6 months, 3 years
Time frame: 3 years
albumin-creatine ratio
Time frame: 3 years
changes in cardiac structure and function
Time frame: 3 years
the changes in renal resistive index
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
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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.
Jean Claude Lubanda, Ass.Prof. MD principal investigator
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renal denervation in people with Arterial Hypertension and Chronic Renal Insufficiency, run by Charles University, Czech Republic at 1 site in Czechia.
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 7 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 6 Dec 2013. 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 Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jean Claude Lubanda, Ass.Prof. MD (+420224962692, Jean-Claude.Lubanda@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of eGFR by MDRD (time frame: 6 months). The study lists 5 primary outcomes in all. 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 6 Dec 2013.