A Long-Term Follow-Up Study of Participants Exposed to REACT
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CKD patients previously treated with REACT Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1). |
Biological: Renal Autologous Cell Therapy (REACT)
No interventions in this trial
|
Outcome Measures
Primary Outcome Measures
- Primary Endpoints is as follows: [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 Outcome Measures
- First Secondary Endpoint [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.
- Second Secondary Endpoint [60 months from completion of parent protocol EOS Visit]
Time from first injection to chronic dialysis.
- Third Secondary Endpoint [60 months from completion of parent protocol EOS Visit]
Time from first injection to renal transplant.
Eligibility Criteria
Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Prokidney
Investigators
- Study Director: Ashley Johns, MSHS, Prokidney
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REGEN-008S1