Renal Denervation in ADPKD- RDN-ADPKD Study

NCT05460169 | Active Not Recruiting DMC

• 1 other identifier: RDN2021ADPKD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

RDN-ADPKD is a prospective, randomized (1:1, central randomization), single-center, hypothesis-generating, feasibility study. The purpose of the RDN-ADPKD study is to demonstrate efficacy and document safety of renal denervation (RDN) with the Paradise System in hypertensive patients with ADPKD.

Conditions

Uncontrolled Hypertension; Renal Denervation; Autosomal Dominant Polycystic Kidney Disease

Keywords

Uncontrolled Hypertension; Autosomal Dominant Polycystic Kidney Disease; Renal denervation

Outcome Measures

Primary Outcomes (1)

• change in systolic 24-h ambulatory BP [whole study group]

  change in systolic 24-h ambulatory BP at 3 months post-procedure from pre-treatment in the whole study group (irrespective whether treated immediate \[I-RDN-group\] or delayed \[D-RDN-group\]).

  3 months post-procedure

Secondary Outcomes (32)

• Change in diastolic 24-h ambulatory BP [whole study group]

  3 months post-procedure

• Change in systolic and diastolic 24-h ambulatory BP [whole study group]

  6, 12, 18, 24, 30, 36 months post-procedure

• Change in systolic and diastolic 24-h ambulatory BP [separate study groups]

  3 months post-procedure

• Responder rate in BP [separate study groups]

  3 months post-procedure

• Change in systolic and diastolic office (attended) BP [whole study group]

  3, 6, 12, 18, 24, 30, 36 months post-procedure

Study Arms (2)

Immediate Renal Denervation Group (I-RDN-group)

ACTIVE COMPARATOR

Patients are randomized into (immediate) I-RDN-group and (delayed) D-RDN-group, respectively. All subjects in the I-RDN-group will undergo a diagnostic, renal angiogram immediately (based on clinical grounds to rule out renal artery stenosis), which should be per Institutional practice via femoral artery access. Renal Denervation procedure will be applied using the Paradise® Renal Denervation System. The Paradise® Renal Denervation System is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.

Device: Renal denervation

Delayed Renal Denervation Group (D-RDN-group)

OTHER

3 months after randomization, patients in the (delayed) D-RDN-group will undergo renal denervation procedure after undergoing a diagnostic, renal angiogram and will be followed for additional 36 months.

Device: Renal denervation

Interventions

Renal denervation DEVICE

The Paradise® Renal Denervation System (Paradise System) is CE-marked in countries accepting the CE mark. The system is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.

Delayed Renal Denervation Group (D-RDN-group); Immediate Renal Denervation Group (I-RDN-group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ADPKD
• Patient is adhering to a stable drug regimen without changes for a minimum of 4 weeks
• Individual is ≥ 18 years of age, both genders are included

You may not qualify if:

• eGFR \< 40ml/min/1.73m² (according to the currently used estimation formulas: MDRD (Modification of Diet in Renal Disease), CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration))
• Anatomically significant renal artery abnormality in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement
• Prior renal denervation procedure
• Office (attended) BP ≥180 mmHg systolic and/or ≥110 mmHg diastolic
• h ambulatory BP ≥160 mmHg systolic
• Other cause of hypertension that can be treated by intervention/surgery (e.g. hemodynamically relevant renal artery stenosis, functional adrenal adenoma)
• Type 1 diabetes mellitus
• Proteinuria (\>3g/g Kreatinin)
• Contraindication to MRI
• Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit
• Subject is pregnant, nursing, or intends to become pregnant
• Enrollment in another interventional research protocol
• Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University Hospital FAU Erlangen-Nürnberg

Erlangen, 91054, Germany

Location

Related Publications (1)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RDN-ADPKD is a prospective, randomized (1:1, central randomization), single-centre, hypothesis-generating, feasibility study. Patients are randomized into I-RDN-group and D-RDN-group, respectively. After 3 months, patients in the D-RDN-group will undergo RDN-procedure and will be followed for additional 36 months. Hence, study design allows several comparisons both of whole study group (at same time-point of follow-up) as well as between I-RDN-group and D-RDN-group.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 15, 2022
• Study Start: June 14, 2022
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)