Diabetic Kidney DiseaseNCT05918523
A Long-Term Follow-Up Study of Participants Exposed to REACT
An observational study of Diabetic Kidney Disease and Chronic Kidney Diseases, run by Prokidney at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Kidney Disease, Chronic Kidney Diseases
- What is being tested?
- Renal Autologous Cell Therapy (REACT)
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to Mar 2028
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with CKD
Who may be able to join
- The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol.
Who cannot join
- The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boise Kidney & Hypertension Institute
Meridian, Idaho, 83642
Arnold Silva, MD
About this study
Official title: A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004
The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).
Read the detailed description
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (RMCL-002, REGEN-003, REGEN-004) will be monitored for up to five years with alternating in clinic and phone visits.
- Conditions
- Diabetic Kidney Disease, Chronic Kidney Diseases
- Being tested
- Renal Autologous Cell Therapy (REACT)
- Keywords
- REACT, DKD, CKD
- Medical subject headings
- Diabetic Nephropathies, 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
No interventions in this trial
| Study group | Role | What they receive |
|---|---|---|
| CKD patients previously treated with REACT | Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1). 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 Endpoint: Long-term safety of REACT
Evaluation of the long-term safety of REACT will be assessed via:
- Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
- Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
- Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
- Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
Measured: 60 months from completion of parent protocol EOS Visit
Secondary outcomes (3)
First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m²
Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.
Measured: 60 months from completion of parent protocol EOS Visit
Second Secondary Endpoint: Time from first injection to chronic dialysis.
Time from first injection to chronic dialysis.
Measured: 60 months from completion of parent protocol EOS Visit
Third Secondary Endpoint: Time from first injection to renal transplant.
Time from first injection to renal transplant.
Measured: 60 months from completion of parent protocol EOS Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start11 Dec 2023
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
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
- NCT05918523
- Sponsor's protocol ID
- REGEN-008S1
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2023
- Last updated
- 1 Sep 2026
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004
- ClinicalTrials.gov ID
- NCT05918523
- Acronym / sponsor ID
- REGEN-008S1
- Conditions
- Diabetic Kidney Disease, Chronic Kidney Diseases
- Keywords
- REACT, DKD, CKD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- ProkidneyIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Jun 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 long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).
Detailed description
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (RMCL-002, REGEN-003, REGEN-004) will be monitored for up to five years with alternating in clinic and phone visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD patients previously treated with REACT | – | Biological: Renal Autologous Cell Therapy (REACT)Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1). |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with CKD
Key inclusion criteria (1 listed)
- The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol.
Key exclusion criteria (1 listed)
- The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.
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)No interventions in this trial | Biological | CKD patients previously treated with REACT |
Primary outcome
Primary Endpoint: Long-term safety of REACT
Time frame: 60 months from completion of parent protocol EOS Visit
Evaluation of the long-term safety of REACT will be assessed via: 1. Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 2. Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 3. Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 4. Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
3 secondary outcomes
First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m²
Time frame: 60 months from completion of parent protocol EOS Visit
Second Secondary Endpoint: Time from first injection to chronic dialysis.
Time frame: 60 months from completion of parent protocol EOS Visit
Third Secondary Endpoint: Time from first injection to renal transplant.
Time frame: 60 months from completion of parent protocol EOS Visit
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 1 Sep 2026.
Related trials for Diabetic Kidney Disease
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
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.
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?
An observational study of Diabetic Kidney Disease and Chronic Kidney Diseases, 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 1 inclusion and 1 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 1 Sep 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 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.
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 Beth Hilburger (336-999-7031, info@prokidney.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint: Long-term safety of REACT (time frame: 60 months from completion of parent protocol EOS Visit). 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 1 Sep 2026.