NCT07483372

Safety and Efficacy of SC101 Via Perirenal Fat Injection for Resistant Hypertension in Patients With Moderate to Severe Chronic Kidney Disease

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Resistant Arterial Hypertension
• Chronic Kidney Disease (Stage 3-4)

Interventions

Type	Name	Description
DRUG	SC101	A single-session bilateral injection of SC101 into the inferior perirenal fat under B-mode ultrasound guidance.

Timeline

• Start date: 2026-03-27
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-19
• Last updated: 2026-04-01

Locations

1 site across 1 country: China