NCT05703620

Brief Summary

The is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Oct 2021May 2026

Study Start

First participant enrolled

October 8, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2026

Expected
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

January 19, 2023

Last Update Submit

January 19, 2023

Conditions

Chronic Kidney DiseasesHeart FailureEnd Stage Renal Disease

Keywords

Renal DenervationSympathetic Nervous System

Outcome Measures

Primary Outcomes (2)

  • Reduction in renal sympathetic nerve activity

    Spillover results

    BASELINE TO 3 MONTHS

  • Reduction in renal sympathetic nerve activity

    Muscle Sympathetic Nerve Activity (MSNA)

    BASELINE TO 12 MONTHS

Secondary Outcomes (1)

  • Blood Pressure

    Baseline to 36 months

Study Arms (3)

Chronic Kidney Disease

EXPERIMENTAL

Renal Denervation

Device: Renal Denervation

Heart Failure

EXPERIMENTAL

Renal Denervation

Device: Renal Denervation

End stage renal disease

EXPERIMENTAL

Renal Denervation

Device: Renal Denervation

Interventions

Renal DenervationDEVICE

All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels

Chronic Kidney DiseaseEnd stage renal diseaseHeart Failure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both Male and female patients
  • Ages between 18-75 years of age
  • Individual is competent and willing to provide written, informed consent to participate in this clinical study with either
  • CKD stage 3a/b or
  • ESRD on stable renal replacement therapy or
  • Mild to moderate heart failure with reduced ejection fraction

You may not qualify if:

  • Ineligible anatomy
  • Prior treatment with other devices for hypertension including but not limited to ROX Coupler (ROX Medical) , Mobius stent, and/or the CVRx (CVRx Inc) barostimulator device.
  • Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
  • Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
  • Individual has clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
  • Individual has been admitted for inpatient hospitalization for decompensated HF in the previous month
  • Female participants of childbearing potential must have a negative pregnancy test prior to treatment.
  • Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
  • Individual is currently enrolled in another investigational drug or device trial. Note: For the purpose of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
  • Individual has a disease or condition (aside from CKD, ESRD, and HFrEF) that may limit their life expectancy to \< 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicHeart FailureKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Markus Schlaich

    Royal Perth Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anu Joyson

CONTACT

92240390anu.joyson@uwa.edu.au

Markus Schlaich

CONTACT

92240382markus.schlaich@uwa.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

October 8, 2021

Primary Completion

May 18, 2025

Study Completion (Estimated)

May 18, 2026

Last Updated

January 30, 2023

Record last verified: 2023-01

Locations

AU(1)