NCT07275788 A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
| NCT ID | NCT07275788 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Regend Therapeutics |
| Condition | Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-01-08 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2026-01-08 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
REGEND003, which consists of human kidney progenitor cells, demonstrates promising potential in repairing kidney injury. The purpose of this study is to assess the saftey and tolerability of REGEND003 on patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease. It is an exploratory study with multi-centered, randomized, controlled, single-blinded, dose-escalated designs.
Eligibility Criteria
Inclusion Criteria: * Male or female, aged 30 to 75 years at the time of signing the informed consent form; * Diagnosed with Type 2 Diabetes Mellitus for at least 1 year; * Diagnosed with Chronic Kidney Disease (CKD); * Voluntarily sign the informed consent form, be able to cooperate in completing study-related procedures and examinations, capable of adequately recording or describing changes in their condition, and demonstrate strong compliance. Exclusion Criteria: * Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant); * At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test. Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well. * Presence of a current or prior history of malignant tumor at screening (with the exception of those with disease-free survival for more than 2 years, or malignancies deemed to be of low aggressiveness as assessed by the investigator). * Patients with Type 1 Diabetes Mellitus; * Patients undergoing regular hemodialysis or peritoneal dialysis; * Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening; * Presence of more than one episode of hypoglycemic coma (blood glucose ≤3.9 mmol/L) within 1 month prior to screening; * Patients intolerant to renal puncture/intrarenal injection procedures; * Patients with diagnosis of acute kidney injury, congenital or hereditary kidney diseases, renal atrophy, or other renal conditions deemed ineligible by the investigator, as well as patients with a history of kidney transplantation at screening; * Presence of severe systemic diseases within 6 months prior to screening and judged by the investigator as unsuitable for the study; * Patients requiring long-term anticoagulant or antiplatelet therapy who, in the investigator's judgment, cannot discontinue medication 1 week prior to renal puncture/intrarenal injection procedures; * Patients with suicidal risk, history of psychiatric disorders, or history of epilepsy at screening; * Patients with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening; * Patients participated in other clinical trials with interventions within 1 month prior to screening; * Subject with assessed survival time of less than 1 year by investigators at screening; * Investigators, co-investigators, study coordinators, employees of participating investigators or research centers, or family members of the above individuals; * Any condition that, in the investigator's judgment, may increase subject risk or interfere with the clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07275788 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07275788 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07275788 currently recruiting?
Yes, NCT07275788 is actively recruiting participants. Contact the research team at yuchen@tongji.edu.cn for enrollment information.
Where is the NCT07275788 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07275788 clinical trial?
NCT07275788 is sponsored by Regend Therapeutics. The trial plans to enroll 15 participants.
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