Kidney Week

Abstract: TH-PO1066

Effect of Ultrasound Renal Denervation in Patients with CKD: A Matched-Controlled Analysis of the RADIANCE Clinical Trial Program

Session Information

• CKD: Therapeutic Advances
  October 24, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Schmieder, Roland E., University Hospital Erlangen, Erlangen, Germany

Roland E. Schmieder, MD, FASN

• Azizi, Michel, Universite Paris-Descartes, Paris, France

Michel Azizi, MD, PhD

• Cohen, Debbie L., University of Pennsylvania, Philadelphia, Pennsylvania, United States

Debbie L. Cohen, MD, FASN

• Rogers, Samantha, Recor Medical, Palo Alto, California, United States

Samantha Rogers

• Mcguire, Maureen, Recor Medical, Palo Alto, California, United States

Maureen Mcguire, PhD

• Mcclure, Candace, North American Science Associates Inc, Minneapolis, Minnesota, United States

Candace Mcclure, PhD

• Kirtane, Ajay J., Columbia University Irving Medical Center, New York, New York, United States

Ajay J. Kirtane, MD

Background

In CKD patients, hyperactivation of the sympathetic nervous activity exacerbates hypertension. Ultrasound renal denervation (uRDN), known to decrease SNS activity, has been shown to lower blood pressure (BP) in hypertension patients. In addition, pilot studies indicate that uRDN could lower BP among CKD patients.

Methods

The RADIANCE clinical program included 3 randomized controlled studies that compared uRDN to sham control in 506 mild-to-moderate and resistant hypertensive patients. Patients were eligible for randomization if daytime ambulatory BP (dABP) was ≥135/85 mmHg after a 4-week stabilization/washout period and eGFR was ≥40 ml/min/1.73m². In a matched analysis, the BP response 2 months after uRDN or sham was compared between patients with eGFR<60 (CKD n=28: 16 uRDN and 12 sham) and patients with eGFR ≥60 (non-CKD n=28: 16 uRDN and 12 sham) who were matched on cohort, treatment arm, sex, race, age (± 8 years), and baseline daytime ambulatory systolic BP (dASBP) (±15mmHg).

Results

In this cohort, 79% were men; 21% were black; and average age was 59 years. At baseline, dABP was 150.8/93.5±10.4/7.0 mmHg vs. 153.4/94.0±9.9/7.8 mmHg (p=0.333), median antihypertensive medications defined daily dose was 2.0 vs 2.5 (p=0.565), and eGFR was 53.2±4.9 vs. 77.6±12.2 ml/min/1.73m² (p<0.001) in CKD vs. non-CKD patients, respectively. At 2-months, there were no differences in changes in dASBP from baseline -7.7±18.7 mmHg vs. -8.7±11.3 or office systolic BP -7.6±19.4 vs. -5.1±17.9 in CKD vs. non-CKD, respectively. Changes in eGFR at 2 months were CKD: +7.4±11.0 vs. non-CKD + 2.2±9.6 (baseline-adj p=0.804). Results were similar when comparing the patients with uRDN only: neither dASBP nor office BP differed between CKD and non-CKD patients. Among CKD only patients, the mean difference in dASBP reduction between uRDN and sham at 2-months was -11.1 mmHg (95% CI: -25.3, 3.1; p adj=0.119) and diastolic ambulatory BP -8.0 mmHg (95% CI: -16.4, 0.3; p adj=0.007).

Conclusion

Among patients with mild CKD in the RADIANCE trials, uRDN reduces BP to the same magnitude in both CKD and non-CKD patients while eGFR was not adversely affected. This analysis supports the use of uRDN in patients with uncontrolled RDN who have stage 3 CKD (40-60 ml/min/1.73m²).

Funding

• Commercial Support – Recor Medical