Renal Sympathetic Modification in Patients With Chronic Renal Failure

Chronic Renal Failure Clinical Trial

Official title:

Renal Sympathetic Modification in Patients With Chronic Renal Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01418560
• Other study ID #: SWAN-RF
• Status: Recruiting
• Phase: N/A
• Start date: August 2011
• Est. completion date: June 2020

Study information

• Verified date: March 2019
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Yuehui Yin, MD
• Phone: 0086-13508335502
• Email: yinyh63[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Procedure:
• renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure

Locations

Country	Name	City	State
China	2ndChongqingMU	Chongqing	Chongqing

Sponsors (3)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University	Chongqing Medical University, Jiangsu Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incident of uremia and dialysis requirement		three years
Secondary	serum creatinine increases into multiples in 1 month follow-up		three years
Secondary	effect of urine microalbumin, urine microalbumin/creatinine, serum creatinine, or 24 hrs urine protein value		three years
Secondary	incidence of composite cardiovascular events		three years