Resistant Arterial HypertensionPhase 1NCT07483372
Safety and Efficacy of SC101 Via Perirenal Fat Injection for Resistant Hypertension in Patients With Moderate to Severe Chronic Kidney Disease
A Phase 1 study testing SC101 in people with Resistant Arterial Hypertension and Chronic Kidney Disease (Stage 3-4), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Resistant Arterial Hypertension, Chronic Kidney Disease (Stage 3-4)
- What is being tested?
- SC101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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.
- Vaccination with live (attenuated) vaccines within 4 weeks before screening or planned during the trial.
- Currently participating in other clinical trials, or received other interventional clinical trial drugs within 3 months prior to enrollment.
- Currently using corticosteroids or immunosuppressants, where the investigator judges that dose adjustments will be required during the trial.
- Women who are breastfeeding.
- Other conditions that the investigator believes may affect compliance or make the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu
Xiangqing Kong, +86 13951610265, kongxq@njmu.edu.cn
About this study
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).
Read the 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:
- To assess the initial effectiveness and durability of BP reduction following a single-session injection of SC101 into the bilateral perirenal fat.
- To validate the "perirenal fat-dorsal root ganglion" axis as a mechanism for hypertension.
- 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.
- Being tested
- SC101
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC101Drug
A single-session bilateral injection of SC101 into the inferior perirenal fat under B-mode ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| SC101 Treatment | Experimental | Every participant in the treatment arm will receive a single-session injection of SC101 into the bilateral perirenal fat. Receives: Drug: SC101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
This includes changes in both 24-hour mean ambulatory systolic blood pressure (BP) and 24-hour mean ambulatory diastolic BP
Measured: Baseline, Months 1, 2, 4, and 6
Change from Baseline in Office Blood Pressure at Months 1, 2, 4, and 6
This includes changes in both Office Systolic Blood Pressure (OSBP) and Office Diastolic Blood Pressure (ODBP)
Measured: Baseline, Months 1, 2, 4, and 6
Response Rate of Office Blood Pressure Lowering at Months 1, 2, 4, and 6
"Response" is defined as achieving target BP (OSBP < 140 mmHg and ODBP < 90 mmHg) or a reduction from baseline of ≥ 10 mmHg in OSBP or ≥ 5 mmHg in ODBP
Measured: Baseline, Months 1, 2, 4, and 6
Percentage of Participants with a Reduction in the Number or Dosage of Baseline Antihypertensive Medications
Evaluation of the proportion of participants who successfully reduced their background medication while maintaining BP control
Measured: Baseline, Months 1, 2, 4, and 6
Incidence of Procedure-Related Adverse Events
This includes procedure-related AEs, procedure-related SAEs, C-reactive protein and acute kidney injury-related biomarkers (e.g., urine NGAL, TIMP-2 and IGFBP-7)
Measured: From the day of injection (Day 1) up to the end of the follow-up (Day 364)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start27 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Resistant Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Municipal Hospital
- Responsible party
- Principal investigator, Xiangqing Kong, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483372
- Sponsor's protocol ID
- SC101-2026P-CRH01
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30301366Li 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.
PubMed 35668093
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of SC101 Via Perirenal Fat Injection for Resistant Hypertension in Patients With Moderate to Severe Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07483372
- Acronym / sponsor ID
- SC101-2026P-CRH01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Suzhou Municipal Hospital
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the initial effectiveness and durability of BP reduction following a single-session injection of SC101 into the bilateral perirenal fat.
- To validate the "perirenal fat-dorsal root ganglion" axis as a mechanism for hypertension.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC101 Treatment | Experimental | Drug: SC101Every participant in the treatment arm will receive a single-session injection of SC101 into the bilateral perirenal fat. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC101A single-session bilateral injection of SC101 into the inferior perirenal fat under B-mode ultrasound guidance. | Drug | SC101 Treatment |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the day of injection (Day 1) up to the end of the follow-up (Day 364)
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
5 secondary outcomes
Change from Baseline in 24-hour mean ambulatory blood pressure at Months 1, 2, 4, and 6
Time frame: Baseline, Months 1, 2, 4, and 6
Change from Baseline in Office Blood Pressure at Months 1, 2, 4, and 6
Time frame: Baseline, Months 1, 2, 4, and 6
Response Rate of Office Blood Pressure Lowering at Months 1, 2, 4, and 6
Time frame: Baseline, Months 1, 2, 4, and 6
Percentage of Participants with a Reduction in the Number or Dosage of Baseline Antihypertensive Medications
Time frame: Baseline, Months 1, 2, 4, and 6
Incidence of Procedure-Related Adverse Events
Time frame: From the day of injection (Day 1) up to the end of the follow-up (Day 364)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 30301366Liu 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.
- Background: PubMed 35668093Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC101 in people with Resistant Arterial Hypertension and Chronic Kidney Disease (Stage 3-4), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangqing Kong, MD, PhD (+86 13951610265, kongxq@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the day of injection (Day 1) up to the end of the follow-up (Day 364)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07483372, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.