Perirenal Fat: A Unique Fat Pad and Potential Target for Cardiovascular Disease.
Bo-Xun Liu, Wei Sun, Xiang-Qing Kong
https://pubmed.ncbi.nlm.nih.gov/30301366Actively Recruiting
Phase 1
Age: 18Years - 65Years
All Genders
ID07483372
Safety and Efficacy of SC101 via Perirenal Fat Injection for Resistant Hypertension in Patients with Moderate to Severe Chronic Kidney Disease
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-04-01
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Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
S
Suzhou Municipal Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new treatment called SC101 for adults aged 18 to 65 who have resistant hypertension and moderate to severe chronic kidney disease (CKD). This early-phase, open-label study explores a single injection of SC101, a small interfering RNA (siRNA) agent, into the perirenal fat, aiming to understand its impact on blood pressure and kidney function. Participants will receive one single-session injection of SC101 into the bilateral perirenal fat guided by ultrasound. The study focuses on the safety of this local injection procedure and measures its initial and lasting effects on blood pressure. The trial also investigates the biological mechanism involving the perirenal fat and nerve connection and explores how the treatment might affect kidney health. During the study, participants will be monitored for adverse events from the day of injection through one year. Blood pressure will be measured at baseline and multiple follow-up visits over six months, including 24-hour ambulatory and office readings. Researchers will also track changes in antihypertensive medication use and monitor kidney function and procedure-related safety. The total follow-up period lasts 364 days after treatment.
CONDITIONS
Brief Title
Safety and Efficacy of SC101 Via Perirenal Fat Injection for Resistant Hypertension in Patients With Moderate to Severe Chronic Kidney Disease
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Estimated glomerular filtration rate (eGFR) between 15 and less than 40 mL/min/1.73m²
- Diagnosed with resistant hypertension with uncontrolled blood pressure despite at least 4 weeks of treatment with at least 3 antihypertensive drugs including one diuretic
- Stable doses of antihypertensive drugs for at least 4 weeks prior to screening and able to maintain stable doses during the run-in period
- Sufficient inferior perirenal fat volume for SC101 injection as judged by the investigator
- Agreement to use effective contraception throughout the trial if applicable, with a negative pregnancy test in women of childbearing potential
- Able to understand and voluntarily sign informed consent and complete the study as required
You will not qualify if you...
- Pseudo-resistant hypertension caused by white-coat effect, poor medication adherence, or secondary hypertension except obstructive sleep apnea
- Confirmed secondary hypertension including renal artery stenosis, primary aldosteronism, pheochromocytoma, aortic coarctation
- Congenital renal abnormalities such as solitary kidney or polycystic kidney disease
- Cardiovascular diseases affecting safety including severe arrhythmias, heart failure class III/IV, recent heart attack or stroke within 6 months, severe structural heart disease
- Abnormal liver function with ALT or AST over twice the upper limit of normal
- Hematological diseases including anemia (hemoglobin <90 g/L) or abnormal coagulation
- Type 1 diabetes or poorly controlled hyperglycemia (HbA1c ≥7.5%)
- Urinary system diseases requiring surgery
- Conditions unable to tolerate perirenal fat injection under local anesthesia
- Contraindications to anesthetics like lidocaine
- Life expectancy less than 1 year
- History of malignant tumors except cured over 5 years ago
- Known AIDS or immunodeficiency with low neutrophil count
- Active liver disease with positive viral hepatitis markers
- Positive syphilis tests
- Recent or planned live vaccination within 4 weeks
- Participation in other clinical trials or recent trial drug use within 3 months
- Current corticosteroid or immunosuppressant use requiring dose adjustment
- Women who are breastfeeding
- Other conditions affecting compliance or suitability as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single session
Participants receive a single-session bilateral injection of SC101 into the inferior perirenal fat under ultrasound guidance.
1 injection visit (in-person)
Follow-up
Duration - Up to 12 months
Participants are monitored for safety and effectiveness, including blood pressure and renal function assessments.
Visits at Baseline, Month 1, 2, 4, and 6 with safety monitoring continued through Day 364
Trial Site Locations
Total: 1 location
1
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Actively Recruiting
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Research Team
X
Xiangqing Kong, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
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Peng Li, Boxun Liu, Xiaoguang Wu...
https://pubmed.ncbi.nlm.nih.gov/35668093