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).
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 Type
OBSERVATIONAL
Enrollment
80
No interventions in this trial
Boise Kidney & Hypertension Institute
Meridian, Idaho, United States
RECRUITINGPrimary Endpoint: Long-term safety of REACT
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.
Time frame: 60 months from completion of parent protocol EOS Visit
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.
Time frame: 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.
Time frame: 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.
Time frame: 60 months from completion of parent protocol EOS Visit
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