Diabetic Kidney DiseasePhase 1NCT05694169
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
A Phase 1 study testing Renal Autologous Cell Therapy (REACT) in people with Diabetic Kidney Disease and CAKUT, run by Prokidney at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Kidney Disease, CAKUT, Chronic Kidney Diseases
- 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
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2023to 13 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.
- The participant is male or female, 30 to 80 years of age on the date of informed consent.
- The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.
- The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.
Who cannot join
- The participant has a history of renal transplantation.
- The participant has received dialysis for more than 30 days.
- The participant has received any other investigational products after completion of REACT injections within 3 months of screening.
- The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.
- The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boise kidney and Hypertension Institute
Boise, Idaho, 83642
About this study
Official title: A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)
The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.
Read the detailed description
A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
- Conditions
- Diabetic Kidney Disease, CAKUT, Chronic Kidney Diseases
- Being tested
- Renal Autologous Cell Therapy (REACT)
- Keywords
- REACT, CAKUT, DKD
- Medical subject headings
- Diabetic Nephropathies, Cakut, 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 | Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection. Receives: Biological: Renal Autologous Cell Therapy (REACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints is as follows:
Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via:
- Biopsy Related SAEs
- Injection Procedure Related SAEs
- Investigational Product Related SAEs
- Treatment-Emergent SAEs.
Measured: through 12 months after last supplemental injection
Secondary outcomes (2)
First Secondary Endpoint
Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD)
Measured: 12 months after the last supplemental injection
Second Secondary Endpoint
Percent of participants who have the same or reduced 2-year risk of ESRD
Measured: 12 months after the last supplemental injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start11 Jul 2023
- Primary completion19 Mar 2024
- Study completion13 May 2024
Why it stopped: business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prokidney
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Prokidney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694169
- Sponsor's protocol ID
- REGEN-015
- Status last verified
- Feb 2025
- First submitted
- 27 Dec 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)
- ClinicalTrials.gov ID
- NCT05694169
- Acronym / sponsor ID
- REGEN-015
- Conditions
- Diabetic Kidney Disease, CAKUT, Chronic Kidney Diseases
- Keywords
- REACT, CAKUT, DKD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ProkidneyIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 23 Jan 2023 (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.
The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.
Detailed description
A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
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)Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.
- The participant is male or female, 30 to 80 years of age on the date of informed consent.
- The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.
- The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.
Key exclusion criteria (5 listed)
- The participant has a history of renal transplantation.
- The participant has received dialysis for more than 30 days.
- The participant has received any other investigational products after completion of REACT injections within 3 months of screening.
- The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.
- The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.
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
Primary Endpoints is as follows:
Time frame: through 12 months after last supplemental injection
Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via: 1. Biopsy Related SAEs 2. Injection Procedure Related SAEs 3. Investigational Product Related SAEs 4. Treatment-Emergent SAEs.
2 secondary outcomes
First Secondary Endpoint
Time frame: 12 months after the last supplemental injection
Second Secondary Endpoint
Time frame: 12 months after the last supplemental injection
Results and safety
The study was stopped early (reason given: business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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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.
Study Director study director
Prokidney
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 Renal Autologous Cell Therapy (REACT) in people with Diabetic Kidney Disease and CAKUT, run by Prokidney at 1 site 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 4 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: stopped early, as of the sponsor's last update on 28 Feb 2025. 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 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 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?
The study was stopped early (reason given: business decision). Results are not available in the source record.
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?
Primary Endpoints is as follows: (time frame: through 12 months after last supplemental 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 28 Feb 2025.