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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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Start Date
March 25, 2026
Primary Completion Date
December 31, 2027
Completion Date
December 31, 2027
Last Updated
March 19, 2026
3
ESTIMATED participants
SC101
DRUG
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
NCT07368946
NCT07058922
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07150338