Chronic Kidney DiseaseRSD4CKDNCT01737138
Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
A study testing RSD and medicine in people with Chronic Kidney Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertension Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- RSD and medicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Apr 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 and ≤75 years of age.
- A serum creatinine level of 1.5 to 5.0 mg per deciliter (133 to 442 μmol per liter), a creatinine clearance of 20 to 70 ml per minute per 1.73 m2, with variations of less than 30 percent in the three months before randomization.
- Persistent proteinuria (defined by urinary protein excretion of more than 0.3 g per day for three or more months which can evacuate urinary tract infection and overt heart failure [a New York Heart Association class of III or IV]).
- Resistant hypertension.
- Nondiabetic renal disease.
- Subject is willing and able to comply with the protocol
- Subject is expected to remain available for follow-up visits at the study center
- Subject Informed Consent.
Who cannot join
- Current treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive drugs.
- Connective-tissue disease.
- Obstructive uropathy.
- Congestive heart failure (New York Heart Association class III or IV).
- Subject has significant renovascular abnormalities (a history of prior renal artery intervention, including balloon angioplasty or stenting; double renal artery on one side, distortion, and extension ), measured by abdominal ultrasound or renal angiograms.
- Subject has a history of myocardial infarction, unstable angina, cerebrovascular accident or alimentary tract hemorrhage in the previous 3 months.
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- Subject with sick sinus syndrome.
- Subject has a history of allergy to contrast media; psychiatric disorders; drug or alcohol abuse; and pregnancy.
- Enrolled in a concurrent study that may confound the results of this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Shan Qi Jun, Professor, 0086 025 68136407, qjshan@njmu.edu.cn
Shan Qi Jun, Professor
About this study
Official title: Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertension
Read the detailed description
Chronic kidney disease(CKD) is a global and growing public health problem, and its frequency increases with age. The major complications of CKD involve losing renal function and cardiovascular disease, which result in significant morbidity, mortality, and cost. The main measures for treatment of CKD are optimizing drug therapy and renal replacement therapy. Optimizing drug therapy, including vascular angiotensin-converting enzyme inhibitors, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on. However, the situation for treatment of CKD is not satisfying. Sympathetic overactivity plays a key role in the development and progression of CKD. Sympathetic nerve activity was increased in patients with all stages of CKD, which was associated with cardiovascular events and all-cause mortality. At the same time, hypertension and proteinuria become the most important risk factor for progression of CKD. Recently, many clinical researches have verified that Catheter-based renal sympathetic denervation can safely be used to substantially reduce muscle and whole-body sympathetic-nerve activity (MSNA) and whole-body norepinephrine spillover. Simultaneously, a marked reduction in blood pressure, sleep apnea severity and urine micro albumin level is apparent, with a improvement glucose tolerance. Sympathetic activation, high norepinephrine level, hypertension, glucose tolerance abnormity, proteinuria and obstructive sleep apnea are all recognized as independent risk factors for the development and progression of CKD. So, we design this randomized parallel control clinical study to demonstrate whether RSD can slow the progression of CKD and reduce the rate of all-cause mortality effectively and securely.
- Conditions
- Chronic Kidney Disease
- Being tested
- RSD, medicine
- Keywords
- Resistant hypertension, All-cause mortality, Renal function
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSDProcedure or surgery
Also called renal sympathetic denervation, renal denervation, renal ablation
Contrast renal angiography(iodixanol) was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About six to nine ablations at 10 W for 1 min each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
medicineDrug
Also called drug
Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on.
| Study group | Role | What they receive |
|---|---|---|
| RSD+Medicine | Active comparator | The investigators will recruit 50 randomised CKD patients who meet the inclusion criteria. First undergo renal artery angiography procedure to confirm anatomy. If renal artery meet the inclusion criteria, give the renal sympathetic denervation. At the same time, we will use optimal medication to protect renal function. Then we will conduct a clinic follow-up and a telephone follow-up e(Total 36 months). Receives: Procedure: RSD |
| Medicine | Placebo comparator | The investigators aslo will recruit 50 randomised CKD patients who meet the inclusion criteria. There are no significant differences in age, gender, race, past medical history,personal history and so on between the two groups. In this group we will use optimal medication just like the RSD+Medicine group. Third we will conduct a clinic and a telephone follow-up(Total 36 months). Receives: Drug: medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality,doubling of the serum creatinine level or end-stage renal disease in patients with chronic kidney disease and resistant hypertension.
Measured: 36 months
Secondary outcomes (8)
Urinary protein excretion and renal function
To evaluation of urinary protein excretion and renal function over time, by the reciprocal of the serum and urinary creatinine level, creatinine clearance and the glomerular filtration rate.
Measured: 36 months
Blood pressure
To study the effect of renal sympathetic denervation on blood pressure in patients with hypertension, which can be measured by ambulatory blood pressure and home blood pressure monitoring.
Measured: 36 months
Blood sugar
In order to study whether RSD can reduce the blood sugar level and insulin resistance of diabetic patients. It will be measured by fasting blood glucose, glycated hemoglobin, fasting insulin .
Measured: 36 months
Cardiac function and structure
The effect of renal sympathetic denervation(RSD) on cardiac function and structure can be measured by echocardiographic(include the degree of cardiac pachynesis, left ventricular ejection fraction，left ventricular end diastolic diameter, ventricular septal thickness and so on).
Measured: 36 months
Arrhythmia
If a new arrhythmia is discovered during the follow-up, it will be recorded. Patients may have symptoms of flustered, palpitations, dizziness, amaurosis, syncope and so on, which can be diagnosed by ECG and Holter.
Measured: 36 months
Pulse wave velocity
So as to study whether RSD can improve the patients' blood vessel elasticity, a pulse wave velocity (PWV)will be carried on.
Measured: 36 months
Life quality
Life quality on 36-item short-form(SF-36),HRQoL and PRODISQ Health Survey Questionnaire will be carried out during the follow-up to study the patients' life quality.
Measured: 36 months
Rehospitalization rate
To study whether RSD can reduce the patients' rehospitalization rate, which will be measured by questionnaire and telephone follow-ups.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2017 (estimated)
- Study completionApr 2018 (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 The First Affiliated Hospital with Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qijun Shan, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Shan Qi Jun, professor, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737138
- Sponsor's protocol ID
- 2012-SR-142
- Acronym
- RSD4CKD
- Status last verified
- Nov 2012
- First submitted
- 27 Nov 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Chronic Kidney Disease and Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01737138
- Acronym / sponsor ID
- RSD4CKD / 2012-SR-142
- Conditions
- Chronic Kidney Disease
- Keywords
- Resistant hypertension, All-cause mortality, Renal function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 29 Nov 2012 (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.
To study whether renal sympathetic denervation(RSD) is safe and effective in patients with chronic kidney disease and resistant hypertension
Detailed description
Chronic kidney disease(CKD) is a global and growing public health problem, and its frequency increases with age. The major complications of CKD involve losing renal function and cardiovascular disease, which result in significant morbidity, mortality, and cost. The main measures for treatment of CKD are optimizing drug therapy and renal replacement therapy. Optimizing drug therapy, including vascular angiotensin-converting enzyme inhibitors, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on. However, the situation for treatment of CKD is not satisfying. Sympathetic overactivity plays a key role in the development and progression of CKD. Sympathetic nerve activity was increased in patients with all stages of CKD, which was associated with cardiovascular events and all-cause mortality. At the same time, hypertension and proteinuria become the most important risk factor for progression of CKD. Recently, many clinical researches have verified that Catheter-based renal sympathetic denervation can safely be used to substantially reduce muscle and whole-body sympathetic-nerve activity (MSNA) and whole-body norepinephrine spillover. Simultaneously, a marked reduction in blood pressure, sleep apnea severity and urine micro albumin level is apparent, with a improvement glucose tolerance. Sympathetic activation, high norepinephrine level, hypertension, glucose tolerance abnormity, proteinuria and obstructive sleep apnea are all recognized as independent risk factors for the development and progression of CKD. So, we design this randomized parallel control clinical study to demonstrate whether RSD can slow the progression of CKD and reduce the rate of all-cause mortality effectively and securely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSD+Medicine | Active comparator | Procedure: RSDThe investigators will recruit 50 randomised CKD patients who meet the inclusion criteria. First undergo renal artery angiography procedure to confirm anatomy. If renal artery meet the inclusion criteria, give the renal sympathetic denervation. At the same time, we will use optimal medication to protect renal function. Then we will conduct a clinic follow-up and a telephone follow-up e(Total 36 months). |
| Medicine | Placebo comparator | Drug: medicineThe investigators aslo will recruit 50 randomised CKD patients who meet the inclusion criteria. There are no significant differences in age, gender, race, past medical history,personal history and so on between the two groups. In this group we will use optimal medication just like the RSD+Medicine group. Third we will conduct a clinic and a telephone follow-up(Total 36 months). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is ≥ 18 and ≤75 years of age.
- A serum creatinine level of 1.5 to 5.0 mg per deciliter (133 to 442 μmol per liter), a creatinine clearance of 20 to 70 ml per minute per 1.73 m2, with variations of less than 30 percent in the three months before randomization.
- Persistent proteinuria (defined by urinary protein excretion of more than 0.3 g per day for three or more months which can evacuate urinary tract infection and overt heart failure [a New York Heart Association class of III or IV]).
- Resistant hypertension.
- Nondiabetic renal disease.
Key exclusion criteria (9 listed)
- Current treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive drugs.
- Connective-tissue disease.
- Obstructive uropathy.
- Congestive heart failure (New York Heart Association class III or IV).
- Subject has significant renovascular abnormalities (a history of prior renal artery intervention, including balloon angioplasty or stenting; double renal artery on one side, distortion, and extension ), measured by abdominal ultrasound or renal angiograms.
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 |
|---|---|---|
| RSDAlso: renal sympathetic denervation, renal denervation, renal ablationContrast renal angiography(iodixanol) was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About six to nine ablations at 10 W for 1 min each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. | Procedure or surgery | RSD+Medicine |
| medicineAlso: drugAngiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on. | Drug | Medicine |
Primary outcome
All-cause mortality, doubling of the serum creatinine level or end-stage renal disease
Time frame: 36 months
To study the effect of renal sympathetic denervation(RSD) on all-cause mortality,doubling of the serum creatinine level or end-stage renal disease in patients with chronic kidney disease and resistant hypertension.
8 secondary outcomes
Urinary protein excretion and renal function
Time frame: 36 months
Blood pressure
Time frame: 36 months
Blood sugar
Time frame: 36 months
Cardiac function and structure
Time frame: 36 months
Arrhythmia
Time frame: 36 months
Pulse wave velocity
Time frame: 36 months
Life quality
Time frame: 36 months
Rehospitalization rate
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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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.
Shan Qi Jun, professor study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RSD and medicine in people with Chronic Kidney Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 8 inclusion and 9 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 3 Dec 2012. 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 China. 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. Some participants in this study may receive a placebo. 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 Shan Qi jun, professor (0086 025 68136407, qjshan@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality, doubling of the serum creatinine level or end-stage renal disease (time frame: 36 months). 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 3 Dec 2012.