New injection aims to tame stubborn high blood pressure in kidney patients
NCT ID NCT07483372
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new medicine called SC101, given as a single injection around the kidneys, for people with resistant high blood pressure and moderate to severe chronic kidney disease. The main goal is to check safety, with only 3 participants. Researchers will also monitor blood pressure changes over 6 months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 3 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic kidney disease (stage 3-4) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Suzhou Municipal Hospital
RECRUITINGSuzhou, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Why do some people with severe obesity develop kidney disease?
- Can a purple berry calm kidney disease inflammation?
- Plant-Based diet and exercise may boost mobility in kidney patients
- Do herbal remedies harm kidneys? new study investigates
- AI-Powered 1-Minute ECG could spot hidden heart risks
- Can a phosphate diet test improve kidney disease care?