Diabetic Kidney DiseaseNCT06790498
Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product
An observational study of Diabetic Kidney Disease and Chronic Kidney Disease, run by Prokidney at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Kidney Disease, Chronic Kidney Disease
- What is being tested?
- Renal Autologous Cell Therapy (REACT)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2023to 31 Aug 2030
- Phase
- Observational
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 Chronic Kidney Disease
Who may be able to join
- The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol.
- The participant is willing and able to cooperate with all aspects of the protocol.
- The participant is willing and able to provide signed informed consent.
Who cannot join
- 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
Boise Kidney & Hypertension Institute
Meridian, Idaho, 83642
About this study
Official title: A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies REGEN-006, REGEN-007, and REGEN-015 (REGEN-008S2)
The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.
Read the detailed description
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) will be monitored for up to five years with alternating in clinic and phone visits.
- Conditions
- Diabetic Kidney Disease, Chronic Kidney Disease
- Being tested
- Renal Autologous Cell Therapy (REACT)
- 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 REGEN-007, REGEN-006, REGEN-015 (REGEN-008S2). Receives: Biological: Renal Autologous Cell Therapy (REACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.
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 (7)
Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.
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
Time from first injection to chronic dialysis.
Time from first injection to chronic dialysis
Measured: 60 months from completion of parent protocol EOS Visit
Time from first injection to renal transplant
Time from first injection to renal transplant
Measured: 60 months from completion of parent protocol EOS Visit
Time from first injection to a cardiovascular death.
Time from first injection to a cardiovascular death.
Measured: 60 months from completion of parent protocol EOS Visit
Time from first injection to a renal death.
Time from first injection to a renal death.
Measured: 60 months from completion of parent protocol EOS Visit
Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD) at Months 12, 24, 36, 48, and 60.
Percent of participants who have the same or reduced 5-year risk of end stage renal
Measured: 60 months from completion of parent protocol EOS Visit
Percent of participants who have the same or reduced 2-year risk of end stage renal disease at Months 12, 24, 36, 48, and 60.
Percent of participants who have the same or reduced 2-year risk of end stage renal
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 posted24 Jan 2025
- Study start23 Nov 2023
- Primary completion31 May 2030 (estimated)
- Study completion31 Aug 2030 (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
- 50 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
- NCT06790498
- Sponsor's protocol ID
- REGEN-008S2
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No