Chronic Kidney Disease, Diabetic Kidney Disease
Conditions
Brief 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.
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.
Interventions
BIOLOGICALRenal Autologous Cell Therapy (REACT)
No interventions in this trial
Sponsors
Prokidney
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
• Participant did not receive REACT in a previous trial for the treatment of chronic kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies. | 60 months from completion of parent protocol EOS Visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation. | 60 months from completion of parent protocol EOS Visit | Time from first injection to eGFR \<15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation. |
| Time from first injection to chronic dialysis. | 60 months from completion of parent protocol EOS Visit | Time from first injection to chronic dialysis |
| Time from first injection to renal transplant | 60 months from completion of parent protocol EOS Visit | Time from first injection to renal transplant |
| Time from first injection to a cardiovascular death. | 60 months from completion of parent protocol EOS Visit | Time from first injection to a cardiovascular death. |
| Time from first injection to a renal death. | 60 months from completion of parent protocol EOS Visit | Time from first injection to a renal death. |
| 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. | 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 |
| 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. | 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 |
Countries
United States
Contacts
STUDY_DIRECTORStudy Director
Prokidney
Outcome results
None listed