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

NCT07483372 | Recruiting Phase 1

• 1 other identifier: SC101-2026P-CRH01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence 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

  From the day of injection (Day 1) up to the end of the follow-up (Day 364)

Secondary Outcomes (5)

• Change from Baseline in 24-hour mean ambulatory blood pressure at Months 1, 2, 4, and 6

  Baseline, Months 1, 2, 4, and 6

• Change from Baseline in Office Blood Pressure at Months 1, 2, 4, and 6

  Baseline, Months 1, 2, 4, and 6

• Response Rate of Office Blood Pressure Lowering at Months 1, 2, 4, and 6

  Baseline, Months 1, 2, 4, and 6

• Percentage of Participants with a Reduction in the Number or Dosage of Baseline Antihypertensive Medications

  Baseline, Months 1, 2, 4, and 6

• Incidence of Procedure-Related Adverse Events

  From the day of injection (Day 1) up to the end of the follow-up (Day 364)

Other Outcomes (2)

• Exploratory Outcome: Change from Baseline in Renal Function Biomarkers at Months 1, 2, 4, and 6

  Baseline, Months 1, 2, 4, and 6

• Exploratory Outcome: Systemic Exposure of SC101

  Baseline, 6 hours, and 12 hours post-injection

Study Arms (1)

SC101 Treatment

EXPERIMENTAL

Every participant in the treatment arm will receive a single-session injection of SC101 into the bilateral perirenal fat.

Drug: SC101

Interventions

SC101 DRUG

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

SC101 Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Obvious pseudo-resistant hypertension caused by white-coat effect, incorrect BP measurement, poor medication adherence, use of drugs affecting antihypertensive efficacy, insufficient dosage, unreasonable combination therapy, or secondary hypertension (except obstructive sleep apnea) as judged by the investigator.
• Confirmed history of secondary hypertension (including but not limited to renal artery stenosis, primary aldosteronism, pheochromocytoma, aortic coarctation, etc.).
• Congenital renal abnormalities that may affect the safety and/or efficacy evaluation of the trial, including but not limited to solitary kidney or polycystic kidney disease.
• Cardiovascular-related diseases that may affect safety evaluation, including but not limited to: uncontrolled symptomatic tachyarrhythmia or bradyarrhythmia (e.g., untreated persistent atrial fibrillation, second-degree or higher heart block, sick sinus syndrome); congestive heart failure NYHA Class III or IV; myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the past 6 months; severe structural heart disease (including moderate or higher valvular lesions, cardiomyopathy, congenital heart disease).
• Abnormal liver function, defined as Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 2 times the Upper Limit of Normal (ULN).
• Hematological diseases that may affect safety evaluation, including but not limited to anemia (Hemoglobin \< 90 g/L) or abnormal coagulation function (INR \> 1.5 or fibrinogen less than the lower limit of normal).
• Type 1 diabetes mellitus or poorly controlled hyperglycemia at screening (defined as HbA1c ≥ 7.5%).
• Urinary system diseases requiring surgical intervention at screening.
• Conditions unable to tolerate perirenal fat injection under local anesthesia, including but not limited to local skin problems or structural abnormalities adjacent to perirenal fat.
• Contraindications related to anesthetics (such as lidocaine).
• Life expectancy \< 1 year.
• History of malignant tumors (except those cured for more than 5 years without recurrence) or confirmed malignant tumors or precancerous lesions.
• Known Acquired Immunodeficiency Syndrome (AIDS) or HIV-positive status, or previous diagnosis of immunodeficiency with absolute neutrophil count \< 1000/mm\^3.
• Active liver disease participants, such as positive HAV antibody, positive HBV markers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, HBV DNA quantification), or positive HCV antibody (HCV Ab) and HCV RNA quantification above the detection limit.
• Positive Syphilis antibody and positive Rapid Plasma Reagin (RPR) test.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Suzhou Municipal Hospital: collaborator

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

RECRUITING

Related Publications (2)

• Liu BX, Sun W, Kong XQ. Perirenal Fat: A Unique Fat Pad and Potential Target for Cardiovascular Disease. Angiology. 2019 Aug;70(7):584-593. doi: 10.1177/0003319718799967. Epub 2018 Oct 9.

  PMID: 30301366 BACKGROUND

• Li P, Liu B, Wu X, Lu Y, Qiu M, Shen Y, Tian Y, Liu C, Chen X, Yang C, Deng M, Wang Y, Gu J, Su Z, Chen X, Zhao K, Sheng Y, Zhang S, Sun W, Kong X. Perirenal adipose afferent nerves sustain pathological high blood pressure in rats. Nat Commun. 2022 Jun 6;13(1):3130. doi: 10.1038/s41467-022-30868-6.

  PMID: 35668093 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiangqing Kong, MD, PhD

CONTACT

+86 13951610265; kongxq@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)