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Tests treatment safety and results for Resistant Arterial Hypertension
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
What this study is testing
What is SC101?
SC101 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for resistant arterial hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- Diagnosed with resistant hypertension: blood pressure (BP) remains uncontrolled after at least 4 weeks of treatment with at least 3 types of...
- Received stable doses of antihypertensive drugs for at least 4 weeks prior to screening, and can accept stable doses of antihypertensive drugs for 2...
- The inferior perirenal fat volume is judged by the investigator to be sufficient for SC101 injection.
You likely can't join if
- Obvious pseudo-resistant hypertension caused by white-coat effect, incorrect BP measurement, poor medication adherence, use of drugs affecting...
- Confirmed history of secondary hypertension (including but not limited to renal artery stenosis, primary aldosteronism, pheochromocytoma, aortic...
- Congenital renal abnormalities that may affect the safety and/or how well it works evaluation of the trial, including but not limited to solitary...
- Cardiovascular-related diseases that may affect safety evaluation, including but not limited to: uncontrolled symptomatic tachyarrhythmia or...
- 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 \ 1.5 or fibrinogen less than the lower...
See the full eligibility 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...
- 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.
- Obvious pseudo-resistant hypertension caused by white-coat effect, incorrect BP measurement, poor medication adherence, use of drugs affecting antihypertensive how well it works, insufficient dosage, unreasonable...
- 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 how well it works 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...
- 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 \ 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.