Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)Phase 1NCT07275788
A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
A Phase 1 study testing REGEND003 in people with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD), run by Regend Therapeutics at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
- What is being tested?
- REGEND003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2026to 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
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
Shanghai Tongji Hospital
Shanghai, 200000
Prof. Yu, 086-021-66111062, yuchen@tongji.edu.cn
About this study
Official title: An Exploratory Study of REGEND003 Kidney Progenitor Cells on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
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.
- Being tested
- REGEND003, Placebo
- Keywords
- Type 2 Diabetes Mellitus, Chronic Kidney Disease, Cell Therapy, Kidney Progenitor Cells
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGEND003Biological
REGEND003
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| REGEND003 | Experimental | REGEND003 for dosage escalation Receives: Biological: REGEND003 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AE) associated with the Cell Therapy
The incidence and severity of adverse events will be evaluated.
Measured: Within 24 weeks post-treatment
Secondary outcomes (11)
Complications associated with Intrarenal Injection
The incidence will be evaluated.
Measured: Within 24 weeks post-treatment
Change from Baseline in Concentration of C-Reactive Protein
C-Reactive Protein is a marker of inflammation in the body.
Measured: Within 24 weeks post-treatment
Change from Baseline in Glomerular Filtration Rate (GFR)
GFR is a critical measurement of kidney function, reflecting how efficiently the kidneys filter blood
Measured: Within 24 weeks post-treatment
Change from Baseline in Concentration of Serum Creatinine
A creatinine test is a measure of how well the kidneys are doing their job of filtering waste from the blood.
Measured: Within 24 weeks post-treatment
Change from Baseline in 24-Hour Urinary Protein Excretion
A 24-hour urine protein test measures the amount of albumin (the most common protein filtered in the kidney) in the urine over 24 hours.
Measured: Within 24 weeks post-treatment
Change from Baseline in Urine Albumin-Creatinine Ratio (uACR)
A urine albumin-creatinine ratio (uACR) is a urine (pee) test that help to understand the overall kidney health. A high uACR may be a sign of kidney disease.
Measured: Within 24 weeks post-treatment
Change from Baseline in Kidney Volume
Kidney volume provides key insights in many clinical situations. Abnormal kidney volumes often signal problems.
Measured: Winthin 24 weeks post-treatment
Change from Baseline in Renal Cortical Thickness (RCT)
RCT has also been used in the diagnosis of chronic kidney disease. With the progression of the disease, RCT decreases.
Measured: Within 24 weeks post-treatment
Changes from Baseline in the Outcomes from Kidney Disease Quality of Life (KDQOL) Survey
The Kidney Disease Quality of Life (KDQOL) survey has long been used to assess the burden, symptoms/problems, and effects of kidney disease on a patient's quality of life. The minimal value is 0 and the maximal value is 100. A higher score means a better outcome.
Measured: Within 24 weeks post-treatment
Change from Baseline in Blood Pressure
Both systolic and diastolic blood pressures are assessed.
Measured: Within 24 weeks post-treatment
Time from Injection to First Kidney Disease Progression (KDP)
KDP is assessed by stage of disease, mortality and continous decreasing of GFR.
Measured: Within 24 weekd post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start8 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275788
- Sponsor's protocol ID
- REGEND003-CKD-001
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of REGEND003 Kidney Progenitor Cells on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT07275788
- Acronym / sponsor ID
- REGEND003-CKD-001
- Keywords
- Type 2 Diabetes Mellitus, Chronic Kidney Disease, Cell Therapy, Kidney Progenitor Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Regend TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Dec 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REGEND003 | Experimental | Biological: REGEND003REGEND003 for dosage escalation |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
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 |
|---|---|---|
| REGEND003REGEND003 | Biological | REGEND003 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Adverse Event (AE) associated with the Cell Therapy
Time frame: Within 24 weeks post-treatment
The incidence and severity of adverse events will be evaluated.
11 secondary outcomes
Complications associated with Intrarenal Injection
Time frame: Within 24 weeks post-treatment
Change from Baseline in Concentration of C-Reactive Protein
Time frame: Within 24 weeks post-treatment
Change from Baseline in Glomerular Filtration Rate (GFR)
Time frame: Within 24 weeks post-treatment
Change from Baseline in Concentration of Serum Creatinine
Time frame: Within 24 weeks post-treatment
Change from Baseline in 24-Hour Urinary Protein Excretion
Time frame: Within 24 weeks post-treatment
Change from Baseline in Urine Albumin-Creatinine Ratio (uACR)
Time frame: Within 24 weeks post-treatment
Change from Baseline in Kidney Volume
Time frame: Winthin 24 weeks post-treatment
Change from Baseline in Renal Cortical Thickness (RCT)
Time frame: Within 24 weeks post-treatment
Changes from Baseline in the Outcomes from Kidney Disease Quality of Life (KDQOL) Survey
Time frame: Within 24 weeks post-treatment
Change from Baseline in Blood Pressure
Time frame: Within 24 weeks post-treatment
Time from Injection to First Kidney Disease Progression (KDP)
Time frame: Within 24 weekd post-treatment
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 17 Mar 2026.
- 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 REGEND003 in people with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD), run by Regend Therapeutics 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 4 inclusion and 18 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 17 Mar 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. Some participants in this study may receive a placebo. 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 Prof. Yu (086-021-66111062, yuchen@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AE) associated with the Cell Therapy (time frame: Within 24 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.