Type 2 Diabetes MellitusPhase 2NCT03270956
A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease
A Phase 2 study testing Renal Autologous Cell Therapy (REACT) in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Prokidney at 4 sites in United States.
Trial summary
The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- What is being tested?
- Renal Autologous Cell Therapy (REACT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Apr 2018to 17 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is male or female, 30 to 65 years of age on the date of informed consent.
- The subject has an established diagnosis of T2DM.
- The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
- The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.
- The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.
- A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.
Who cannot join
- The subject has a history of type 1 diabetes mellitus.
- The subject has a history of renal transplantation.
- The subject has a serum HbA1c level greater than 10% at the Screening Visit.
- The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
- The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Boise Kidney & Hypertension Institute
Boise, Idaho, 83642
University of North Carolina- Chapel Hill
Chapel Hill, North Carolina, 27599
Vanderbilt University [WITHDRAWN]
Nashville, Tennessee, 37212
University of Arizona [WITHDRAWN]
Tucson, Arizona, 85724
About this study
Official title: A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)
The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).
Read the detailed description
All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- Being tested
- Renal Autologous Cell Therapy (REACT)
- 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.
Renal Autologous Cell Therapy (REACT)Biological
Autologous selected renal cells (SRC)
| Study group | Role | What they receive |
|---|---|---|
| Renal Autologous Cell Therapy (REACT) | Experimental | Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available. Receives: Biological: Renal Autologous Cell Therapy (REACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure and/or Product Related Adverse Events
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
Measured: Through 24 months following last REACT injection
Secondary outcomes (1)
Renal Specific Adverse Events
Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term
Measured: Through 24 months following last REACT injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start25 Apr 2018
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prokidney
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Responsible party
- Sponsor
- Investigators
- Ashley Johns, Study director, Prokidney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270956
- Sponsor's protocol ID
- REGEN-003
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2017
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)
- ClinicalTrials.gov ID
- NCT03270956
- Acronym / sponsor ID
- REGEN-003
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ProkidneyIndustry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).
Detailed description
All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Autologous Cell Therapy (REACT) | Experimental | Biological: Renal Autologous Cell Therapy (REACT)Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is male or female, 30 to 65 years of age on the date of informed consent.
- The subject has an established diagnosis of T2DM.
- The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
- The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.
- The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.
Key exclusion criteria (5 listed)
- The subject has a history of type 1 diabetes mellitus.
- The subject has a history of renal transplantation.
- The subject has a serum HbA1c level greater than 10% at the Screening Visit.
- The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
- The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.
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 |
|---|---|---|
| Renal Autologous Cell Therapy (REACT)Autologous selected renal cells (SRC) | Biological | Renal Autologous Cell Therapy (REACT) |
Primary outcome
Procedure and/or Product Related Adverse Events
Time frame: Through 24 months following last REACT injection
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
1 secondary outcome
Renal Specific Adverse Events
Time frame: Through 24 months following last REACT injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Ashley Johns study director
Prokidney
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Renal Autologous Cell Therapy (REACT) in people with Type 2 Diabetes Mellitus and Chronic Kidney Disease, run by Prokidney at 4 sites in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure and/or Product Related Adverse Events (time frame: Through 24 months following last REACT injection). 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 24 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.