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

September 23, 2014 updated by: Mei changlin

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Recruiting
        • Department of Nephrology, Shanghai Changzheng Hospital
        • Sub-Investigator:
          • Lin Li, PHD
        • Sub-Investigator:
          • Xueqi Wang, PHD
        • Sub-Investigator:
          • Chenggang Xu, PHD
        • Sub-Investigator:
          • Zhiguo Mao, PHD
        • Sub-Investigator:
          • Bing Dai, PHD
        • Sub-Investigator:
          • Yiyi Ma, Master
        • Sub-Investigator:
          • Dongping Chen, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: renal sympathetic denervation
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).
Procedure: renal sympathetic denervation
One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.
Other Names:
  • renal denervation
  • renal ablation
  • Percutaneous radiofrequency ablation of renal nerves
  • Transcatheter renal denervation
Drug: antihypertensive drugs
antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.
ACTIVE_COMPARATOR: antihypertensive drugs
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)
Drug: antihypertensive drugs
antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
office-based measurements of systolic blood pressure
Time Frame: baseline and 12 months (day 360±14)
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.
baseline and 12 months (day 360±14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM)
Time Frame: baseline and 12 months (day 360±14)
Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) from baseline to 12 month.
baseline and 12 months (day 360±14)
Incidence of office systolic blood pressure reduction
Time Frame: baseline and 12 months (day 360±14)
Incidence of office systolic blood pressure reductions of ≥10, ≥15 and ≥20 mm Hg from baseline to 12 month.
baseline and 12 months (day 360±14)
office diastolic blood pressure
Time Frame: baseline and 12 months (day 360±14)
Change in office diastolic blood pressure from baseline to 12 months.
baseline and 12 months (day 360±14)
number and dosage of blood pressure tablets
Time Frame: baseline and 12 months (day 360±14)
Change in number and dosage of blood pressure tablets from baseline to 12 months.
baseline and 12 months (day 360±14)
estimated Glomerular Filtration Rate(eGFR)
Time Frame: baseline and 12 months (day 360±14)
Change in estimated Glomerular Filtration Rate(eGFR) from baseline to 12 months.
baseline and 12 months (day 360±14)
albuminuria
Time Frame: baseline and 12 months (day 360±14)
Change in albuminuria from baseline to 12 months.
baseline and 12 months (day 360±14)
total kidney volume (TKV)
Time Frame: baseline and 12 months (day 360±14)
Change in total kidney volume (TKV) from baseline to 12 months
baseline and 12 months (day 360±14)
pain
Time Frame: baseline and 12 months (day 360±14)
Change in pain related to cystic kidneys from baseline to 12 months.
baseline and 12 months (day 360±14)
procedure-related complications at femoral puncture site
Time Frame: up to 1 year (after radiofrequency ablation)
Occurrence of procedure-related complications at femoral puncture site (hematoma, arteriovenous fistula, pseudoaneurysma).
up to 1 year (after radiofrequency ablation)
Renal artery lesion
Time Frame: up to 1 year (after radiofrequency ablation)
Renal artery lesion (perforation or dissection).
up to 1 year (after radiofrequency ablation)
New renal artery stenosis
Time Frame: up to 1 year (after radiofrequency ablation)
New renal artery stenosis >70%, determined by MRI within 12 months of randomization.
up to 1 year (after radiofrequency ablation)
Embolic events
Time Frame: up to 1 year (after radiofrequency ablation)
Embolic events.
up to 1 year (after radiofrequency ablation)
hypotension
Time Frame: up to 1 year (after radiofrequency ablation)
Episodes of hypotension.
up to 1 year (after radiofrequency ablation)
hypertension.
Time Frame: up to 1 year (after radiofrequency ablation)
Episodes of hypertension.
up to 1 year (after radiofrequency ablation)
acute kidney injury
Time Frame: up to 1 year (after radiofrequency ablation)
Acute deterioration of renal function
up to 1 year (after radiofrequency ablation)
total cyst volume (TCV)
Time Frame: baseline and 12 months (day 360±14)
Change in total cyst volume (TCV) from baseline to 12 months
baseline and 12 months (day 360±14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mei changlin

Investigators

  • Principal Investigator: Changlin Mei, MD, Nephrology Department of Shanghai Changzheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

July 1, 2015

Study Registration Dates

First Submitted

August 18, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (ESTIMATE)

August 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZKIPLA-ADPKD-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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