Renal Sympathetic Modification in Patients With Chronic Renal Failure

The purpose of this study is to observe the incident of uremia and dialysis requirement after renal sympathetic modification using THERMOCOOL® catheter in patients with chronic renal failure, and evaluate safety and efficacy of the intervention.

Study Overview

• Status: Unknown
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Procedure: renal sympathetic modification

Detailed Description

Chronic renal failure is serial clinical manifestations because of kidney damage. Previous studies found sympathetic nerves over activity in chronic renal failure patients. Traditional therapies included medications and dialysis replacement therapy need to spend much money. Renal ablation for sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of chronic renal failure. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary medications besides expectant intervention, and patients in control group will receive appropriate medications only. We aim to observe the effect of serum creatinine, creatinine clearance rate, glomerular filtration rate, urine microalbumin, urine microalbumin/creatinine, and composite cardio cerebrovascular events after renal sympathetic modification using THERMOCOOL® catheter, and evaluate safety and efficacy of the intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • 2ndChongqingMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 18 years old, and ≤ 75 years old of age
• at least three months history of definite kidney damage
• renal function of serum creatinine of < 354umol/L, and/or creatinine clearance rate of ≥ 30ml/min, and/or estimated glomerular filtration rate of ≥ 45ml/min for recent 2-3 times evaluation. Besides, the value of creatinine clearance rate fluctuated no more than 30% in recent three months, and 15% in the following two weeks.
• urine microalbumin, and/or urine microalbumin/creatinine is abnormal, and/or quantity of 24 hrs urine protein suggests kidney damage.
• is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

• congenital renal diseases cause to chronic renal damage
• estimated glomerular filtration rate (eGFR) of < 45mL/min
• taking medicine of glucocorticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), or cytotoxic drugs at present
• value of 24 hrs urine protein is of > 10g at least once in recent three months, or serum albumin of < 25g/L
• has the history of renal restenosis or renal stents implantation
• has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months
• carcinoma patients
• patients with sick sinus syndrome
• pregnant women
• mental disorders
• patients that have allergy to contrast agent
• patients that do not go with follow-up
• others such as researcher considers it is not appropriate to be included into the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: renal sympathetic modification; Renal artery ablation to modify sympathetic activity in patients with chronic renal failure.	Procedure: renal sympathetic modification; Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure; Other Names: renal denervation
NO_INTERVENTION: Absolute medicine therapy; Maintenance of anti-renal failure medications only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the incident of uremia and dialysis requirement	three years

Secondary Outcome Measures

Outcome Measure	Time Frame
serum creatinine increases into multiples in 1 month follow-up	three years
effect of urine microalbumin, urine microalbumin/creatinine, serum creatinine, or 24 hrs urine protein value	three years
incidence of composite cardiovascular events	three years

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Collaborators: Chongqing Medical University; Jiangsu Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (ESTIMATE): August 17, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: chronic renal failure; renal artery; sympathetic nerves; modification
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: SWAN-RF