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Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control (RAFALE)

Primary Purpose

Autosomal Dominant Polycystic Kidney Disease, Hypertension

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
renal sympathetic denervation
antihypertensive drugs
Sponsored by
Mei changlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease focused on measuring hypertension, radiofrequency ablation, autosomal dominant polycystic kidney disease

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with ADPKD.
  • Having hypertension, defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, and currently using 2 antihypertensive drugs and receiving a stable antihypertensive treatment regimen without change in dose or medication in the previous 30 days.
  • Male and female patients 20 years to 60 years of age.
  • Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2, estimated from serum creatinine using the Chronic Kidney Disease Epidemiology collaboration(CKD-EPI) equation.
  • Have followed-up kidney and cyst volume at least 6 months in Shanghai Changzheng Hospital.
  • Signed Informed Consent after being informed.

Exclusion Criteria:

  • Documented renal vascular disease.
  • Congenital absence of a kidney.
  • Systemic illness with renal involvement.
  • Spot urine albumin-to-creatinine ratio of >0.5 g/g and/or findings suggestive of kidney disease other than ADPKD.
  • Exclusions specific to MRI acquisition and measurement: cardiac pacemaker, presence of MRI incompatible metallic clips or other material, excessive body weight, untreatable claustrophobia.
  • Contraindications to the catheter-based renal denervation procedure by RFA, including allergy to radioiodinated contrast agents. Anatomical abnormalities of the renal arteries which preclude RFA: presence in either kidneys of multiple main renal arteries, main renal artery stenosis >50%, or main renal arteries of <4 mm in diameter or <20 mm in length.
  • Contraindications on ethical grounds.
  • Women who are pregnant or breast feeding.
  • Intention to become pregnant during the course of the study.
  • Lack of safe contraception: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential).
  • Other clinically significant concomitant disease states (hepatic dysfunction, cardiovascular disease, metastatic cancer).
  • Known or suspected non-compliance, drug or alcohol abuse.
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject.
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.
  • Previous enrolment into the current study.
  • Enrolment of the investigator, his/her family members, employees and other dependent persons.

Sites / Locations

  • Department of Nephrology, Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

renal sympathetic denervation

antihypertensive drugs

Arm Description

One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation and using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).

Blood pressure control in ADPKD patients with hypertension only using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB)

Outcomes

Primary Outcome Measures

office-based measurements of systolic blood pressure
Between-group change in average office-based measurements of systolic blood pressure from baseline to 12 months after randomization and One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation.

Secondary Outcome Measures

24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.
Incidence of office systolic blood pressure reduction
Incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg from baseline to 12 month.
office diastolic blood pressure
Change in office diastolic blood pressure from baseline to 12 months.
number and dosage of blood pressure tablets
Change in number and dosage of blood pressure tablets from baseline to 12 months.
estimated Glomerular Filtration Rate(eGFR)
Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.
albuminuria
Change in albuminuria from baseline to 12 months.
total kidney volume (TKV)
Change in total kidney volume (TKV) from baseline to 12 months
pain
Change in pain related to cystic kidneys from baseline to 12 months.
procedure-related complications at femoral puncture site
Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).
Renal artery lesion
Renal artery lesion (perforation or dissection).
New renal artery stenosis
New renal artery stenosis >70%, determined by MRI within 12 months of randomization.
Embolic events
Embolic events.
hypotension
Episodes of hypotension.
hypertension.
Episodes of hypertension.
acute kidney injury
Acute deterioration of renal function
total cyst volume (TCV)
Change in total cyst volume (TCV) from baseline to 12 months

Full Information

First Posted
August 18, 2013
Last Updated
September 23, 2014
Sponsor
Mei changlin
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1. Study Identification

Unique Protocol Identification Number
NCT01932450
Brief Title
Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control
Acronym
RAFALE
Official Title
A Randomized, Open-label Study Investigating the Effect of Bilateral Renal Artery Sympathetic Denervation by Catheter-based Radiofrequency Ablation on Blood Pressure and Disease Progression in Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mei changlin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized, open-label single-center study investigates the efficacy and safety of bilateral renal artery sympathetic denervation by catheter-based radiofrequency ablation on blood pressure and disease progression control in autosomal dominant polycystic kidney disease(ADPKD). The total number of study subjects will be 100. All of them have diagnosed with ADPKD and hypertension. Patients will be randomized 1:1 (50 with radiofrequency ablation(RFA), 50 only with drugs). Change in average office-based measurements of systolic blood pressure(SBP), average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) , incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg , office diastolic blood pressure (DBP), number and dosage of blood pressure tablets, total kidney volume (TKV), total cyst volume (TCV), pain related to cystic kidneys and renal function, will be assessed at 12 months of follow-up. The safety variables will be assessed at every visit of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease, Hypertension
Keywords
hypertension, radiofrequency ablation, autosomal dominant polycystic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
renal sympathetic denervation
Arm Type
Experimental
Arm Description
One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation and using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
Arm Title
antihypertensive drugs
Arm Type
Active Comparator
Arm Description
Blood pressure control in ADPKD patients with hypertension only using antihypertensive drugs which at least include an angiotensin converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB)
Intervention Type
Procedure
Intervention Name(s)
renal sympathetic denervation
Other Intervention Name(s)
Percutaneous radiofrequency ablation of renal nerves, Transcatheter renal denervation, renal denervation, renal ablation
Intervention Description
One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.
Intervention Type
Drug
Intervention Name(s)
antihypertensive drugs
Intervention Description
antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.
Primary Outcome Measure Information:
Title
office-based measurements of systolic blood pressure
Description
Between-group change in average office-based measurements of systolic blood pressure from baseline to 12 months after randomization and One-time standard bilateral renal sympathetic denervation by catheter-based radiofrequency ablation.
Time Frame
baseline and 12 months (day 360±14)
Secondary Outcome Measure Information:
Title
24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
Description
Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.
Time Frame
baseline and 12 months (day 360±14)
Title
Incidence of office systolic blood pressure reduction
Description
Incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg from baseline to 12 month.
Time Frame
baseline and 12 months (day 360±14)
Title
office diastolic blood pressure
Description
Change in office diastolic blood pressure from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
number and dosage of blood pressure tablets
Description
Change in number and dosage of blood pressure tablets from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
estimated Glomerular Filtration Rate(eGFR)
Description
Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
albuminuria
Description
Change in albuminuria from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
total kidney volume (TKV)
Description
Change in total kidney volume (TKV) from baseline to 12 months
Time Frame
baseline and 12 months (day 360±14)
Title
pain
Description
Change in pain related to cystic kidneys from baseline to 12 months.
Time Frame
baseline and 12 months (day 360±14)
Title
procedure-related complications at femoral puncture site
Description
Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).
Time Frame
up to 1 year (after radiofrequency ablation)
Title
Renal artery lesion
Description
Renal artery lesion (perforation or dissection).
Time Frame
up to 1 year (after radiofrequency ablation)
Title
New renal artery stenosis
Description
New renal artery stenosis >70%, determined by MRI within 12 months of randomization.
Time Frame
up to 1 year (after radiofrequency ablation)
Title
Embolic events
Description
Embolic events.
Time Frame
up to 1 year (after radiofrequency ablation)
Title
hypotension
Description
Episodes of hypotension.
Time Frame
up to 1 year (after radiofrequency ablation)
Title
hypertension.
Description
Episodes of hypertension.
Time Frame
up to 1 year (after radiofrequency ablation)
Title
acute kidney injury
Description
Acute deterioration of renal function
Time Frame
up to 1 year (after radiofrequency ablation)
Title
total cyst volume (TCV)
Description
Change in total cyst volume (TCV) from baseline to 12 months
Time Frame
baseline and 12 months (day 360±14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ADPKD. Having hypertension, defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg, and currently using 2 antihypertensive drugs and receiving a stable antihypertensive treatment regimen without change in dose or medication in the previous 30 days. Male and female patients 20 years to 60 years of age. Glomerular Filtration Rate (GFR) ≥30 ml/min/1.73 m2, estimated from serum creatinine using the Chronic Kidney Disease Epidemiology collaboration(CKD-EPI) equation. Have followed-up kidney and cyst volume at least 6 months in Shanghai Changzheng Hospital. Signed Informed Consent after being informed. Exclusion Criteria: Documented renal vascular disease. Congenital absence of a kidney. Systemic illness with renal involvement. Spot urine albumin-to-creatinine ratio of >0.5 g/g and/or findings suggestive of kidney disease other than ADPKD. Exclusions specific to MRI acquisition and measurement: cardiac pacemaker, presence of MRI incompatible metallic clips or other material, excessive body weight, untreatable claustrophobia. Contraindications to the catheter-based renal denervation procedure by RFA, including allergy to radioiodinated contrast agents. Anatomical abnormalities of the renal arteries which preclude RFA: presence in either kidneys of multiple main renal arteries, main renal artery stenosis >50%, or main renal arteries of <4 mm in diameter or <20 mm in length. Contraindications on ethical grounds. Women who are pregnant or breast feeding. Intention to become pregnant during the course of the study. Lack of safe contraception: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential). Other clinically significant concomitant disease states (hepatic dysfunction, cardiovascular disease, metastatic cancer). Known or suspected non-compliance, drug or alcohol abuse. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject. Participation in another study with investigational drug within the 30 days preceding and during the present study. Previous enrolment into the current study. Enrolment of the investigator, his/her family members, employees and other dependent persons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changlin Mei, MD
Phone
+86 21 81885391
Email
chlmei1954@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yiyi Ma, Master
Phone
+8613661679863
Email
dukemm@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
Organizational Affiliation
Nephrology Department of Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
Phone
+862181885391
Email
chlmei1954@126.com
First Name & Middle Initial & Last Name & Degree
Yiyi Ma, Master
Phone
+8613661679863
Email
dukemm@126.com
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
First Name & Middle Initial & Last Name & Degree
Shengqiang Yu, PHD
First Name & Middle Initial & Last Name & Degree
Lin Li, PHD
First Name & Middle Initial & Last Name & Degree
Xueqi Wang, PHD
First Name & Middle Initial & Last Name & Degree
Chenggang Xu, PHD
First Name & Middle Initial & Last Name & Degree
Zhiguo Mao, PHD
First Name & Middle Initial & Last Name & Degree
Bing Dai, PHD
First Name & Middle Initial & Last Name & Degree
Yiyi Ma, Master
First Name & Middle Initial & Last Name & Degree
Dongping Chen, Master

12. IPD Sharing Statement

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Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control

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