Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01932450
• Date of registration: 18/08/2013
• Prospective Registration: No
• Primary sponsor: Mei changlin
• Public title: Radiofrequency Ablation for ADPKD Blood Pressure and Disease Progression Control RAFALE
• Scientific 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
• Date of first enrolment: August 2013
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01932450
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Changlin Mei, MD

• Name: Changlin Mei, MD
• Affiliation: Nephrology Department of Shanghai Changzheng Hospital

• Name: Changlin Mei, MD

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypertension

Autosomal Dominant Polycystic Kidney Disease

Intervention(s)

Drug: antihypertensive drugs

Procedure: renal sympathetic denervation

Primary Outcome(s)

office-based measurements of systolic blood pressure [Time Frame: baseline and 12 months (day 360±14)]

Secondary Outcome(s)

acute kidney injury [Time Frame: up to 1 year (after radiofrequency ablation)]

estimated Glomerular Filtration Rate(eGFR) [Time Frame: baseline and 12 months (day 360±14)]

New renal artery stenosis [Time Frame: up to 1 year (after radiofrequency ablation)]

procedure-related complications at femoral puncture site [Time Frame: up to 1 year (after radiofrequency ablation)]

hypotension [Time Frame: up to 1 year (after radiofrequency ablation)]

number and dosage of blood pressure tablets [Time Frame: baseline and 12 months (day 360±14)]

total kidney volume (TKV) [Time Frame: baseline and 12 months (day 360±14)]

Embolic events [Time Frame: up to 1 year (after radiofrequency ablation)]

total cyst volume (TCV) [Time Frame: baseline and 12 months (day 360±14)]

24-hour systolic blood pressure by ambulatory blood pressure monitoring (ABPM) [Time Frame: baseline and 12 months (day 360±14)]

Incidence of office systolic blood pressure reduction [Time Frame: baseline and 12 months (day 360±14)]

Renal artery lesion [Time Frame: up to 1 year (after radiofrequency ablation)]

albuminuria [Time Frame: baseline and 12 months (day 360±14)]

hypertension. [Time Frame: up to 1 year (after radiofrequency ablation)]

office diastolic blood pressure [Time Frame: baseline and 12 months (day 360±14)]

pain [Time Frame: baseline and 12 months (day 360±14)]

Secondary ID(s)

CZKIPLA-ADPKD-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors