Safety and Efficacy of SC101 Via Perirenal Fat Injection for Resistant Hypertension in Patients W… (NCT07483372) | Clinical Trial Compass
RecruitingPhase 1
Safety and Efficacy of SC101 Via Perirenal Fat Injection for Resistant Hypertension in Patients With Moderate to Severe Chronic Kidney Disease
China3 participantsStarted 2026-03-27
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 and ≤ 65 years.
* Participants with an estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73m\^2 and \<40 mL/min/1.73m\^2 during the screening period (eGFR is calculated using the Cockcroft-Gault equation).
* Diagnosed with resistant hypertension: blood pressure (BP) remains uncontrolled after at least 4 weeks of treatment with at least 3 types of antihypertensive drugs (including one diuretic) at tolerated and sufficient doses, in addition to lifestyle modification. At the end of the screening and run-in period (baseline), resting office systolic BP (OSBP) ≥ 140 mmHg, resting office diastolic BP (ODBP) ≥ 90 mmHg, and 24-hour mean ambulatory systolic BP (MASBP) ≥ 130 mmHg.
* Received stable doses of antihypertensive drugs for at least 4 weeks prior to screening, and can accept stable doses of antihypertensive drugs for 2 weeks during the run-in period.
* The inferior perirenal fat volume is judged by the investigator to be sufficient for SC101 injection.
* Agreement to use effective contraceptive measures throughout the trial (within 1 year after SC101 injection), and women of childbearing potential must have a negative pregnancy test during the screening period.
* Capable of understanding and voluntarily signing the informed consent form, and able to complete the study in accordance with the protocol requirements.
Exclusion Criteria:
* Obvious pseudo-resistant hypertension caused by white-coat effect, incorrect BP measurement, poor med…
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From the day of injection (Day 1) up to the end of the follow-up (Day 364)
Trial details
NCT IDNCT07483372
SponsorThe First Affiliated Hospital with Nanjing Medical University