This is a single-center, open-label, exploratory clinical study designed to evaluate the safety and efficacy of a single-session injection of SC101, a small interfering RNA (siRNA) agent, into the perirenal fat. This study plans to enroll 3 participants, aged 18 to 65 years, who have a clinical diagnosis of resistant hypertension and moderate to severe chronic kidney disease (CKD).
This is a single-center, open-label, investigator-initiated, exploratory clinical trial. It serves as a proof-of-concept study for a novel anti-hypertensive intervention: the local injection of SC101, a siRNA agent, into the perirenal adipose tissue. This study plans to enroll 3 participants, aged 18 to 65 years, who have a clinical diagnosis of resistant hypertension and moderate to severe CKD. "Resistant hypertension" is defined as blood pressure (BP) that remains uncontrolled despite the use of at least 3 antihypertensive drug classes (including one diuretic) administered at stable, tolerated, and appropriate doses for at least 4 weeks, alongside lifestyle modifications. "Moderate to severe CKD" is defined as as an estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73m\^2 and \<40 mL/min/1.73m\^2 using the Cockcroft-Gault equation. * Study Objectives: * Primary Objective: To evaluate the safety of a single-session injection of SC101 into the bilateral perirenal fat in patients with resistant hypertension and concomitant moderate to severe CKD. * Secondary Objectives: 1. To assess the initial effectiveness and durability of BP reduction following a single-session injection of SC101 into the bilateral perirenal fat. 2. To validate the "perirenal fat-dorsal root ganglion" axis as a mechanism for hypertension. 3. To evaluate the safety profile specifically associated with the perirenal fat injection procedure, providing a basis for establishing localized siRNA interference technique. * Exploratory Objective: To explore the impact of a single-session injection of SC101 on renal function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
A single-session bilateral injection of SC101 into the inferior perirenal fat under B-mode ultrasound guidance.
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
RECRUITINGIncidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety and tolerability assessments include AEs, SAEs, vital signs, physical exams, 12-lead electrocardiography, echocardiography, carotid and renal ultrasound, limb pulse wave velocity, and laboratory tests
Time frame: From the day of injection (Day 1) up to the end of the follow-up (Day 364)
Change from Baseline in 24-hour mean ambulatory blood pressure at Months 1, 2, 4, and 6
This includes changes in both 24-hour mean ambulatory systolic blood pressure (BP) and 24-hour mean ambulatory diastolic BP
Time frame: Baseline, Months 1, 2, 4, and 6
Change from Baseline in Office Blood Pressure at Months 1, 2, 4, and 6
This includes changes in both Office Systolic Blood Pressure (OSBP) and Office Diastolic Blood Pressure (ODBP)
Time frame: Baseline, Months 1, 2, 4, and 6
Response Rate of Office Blood Pressure Lowering at Months 1, 2, 4, and 6
"Response" is defined as achieving target BP (OSBP \< 140 mmHg and ODBP \< 90 mmHg) or a reduction from baseline of ≥ 10 mmHg in OSBP or ≥ 5 mmHg in ODBP
Time frame: Baseline, Months 1, 2, 4, and 6
Percentage of Participants with a Reduction in the Number or Dosage of Baseline Antihypertensive Medications
Evaluation of the proportion of participants who successfully reduced their background medication while maintaining BP control
Time frame: Baseline, Months 1, 2, 4, and 6
Incidence of Procedure-Related Adverse Events
This includes procedure-related AEs, procedure-related SAEs, C-reactive protein and acute kidney injury-related biomarkers (e.g., urine NGAL, TIMP-2 and IGFBP-7)
Time frame: From the day of injection (Day 1) up to the end of the follow-up (Day 364)
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