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Renal Sympathetic Modification in Patients With Chronic Renal Failure

Primary Purpose

Chronic Renal Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
renal sympathetic modification
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring renal artery, sympathetic nerves, modification, chronic renal failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2ndChongqingMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

renal sympathetic modification

Absolute medicine therapy

Arm Description

Renal artery ablation to modify sympathetic activity in patients with chronic renal failure.

Maintenance of anti-renal failure medications only

Outcomes

Primary Outcome Measures

the incident of uremia and dialysis requirement

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2011
Last Updated
March 18, 2019
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Jiangsu Provincial People's Hospital, Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01418560
Brief Title
Renal Sympathetic Modification in Patients With Chronic Renal Failure
Official Title
Renal Sympathetic Modification in Patients With Chronic Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Jiangsu Provincial People's Hospital, Chongqing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
renal artery, sympathetic nerves, modification, chronic renal failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
renal sympathetic modification
Arm Type
Experimental
Arm Description
Renal artery ablation to modify sympathetic activity in patients with chronic renal failure.
Arm Title
Absolute medicine therapy
Arm Type
No Intervention
Arm Description
Maintenance of anti-renal failure medications only
Intervention Type
Procedure
Intervention Name(s)
renal sympathetic modification
Other Intervention Name(s)
renal denervation
Intervention Description
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Primary Outcome Measure Information:
Title
the incident of uremia and dialysis requirement
Time Frame
three years
Secondary Outcome Measure Information:
Title
serum creatinine increases into multiples in 1 month follow-up
Time Frame
three years
Title
effect of urine microalbumin, urine microalbumin/creatinine, serum creatinine, or 24 hrs urine protein value
Time Frame
three years
Title
incidence of composite cardiovascular events
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuehui Yin, MD
Phone
0086-13508335502
Email
yinyh63@163.com
Facility Information:
Facility Name
2ndChongqingMU
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD
Phone
0086-23-63693766
Email
yinyh63@163.com
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD

12. IPD Sharing Statement

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Renal Sympathetic Modification in Patients With Chronic Renal Failure

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