NCT05918523Recruiting
A Long-Term Follow-Up Study of Participants Exposed to REACT
Prokidney
Start Date
12/11/2023
Completion Date
3/1/2028
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).
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.
Eligibility Criteria
Age Range: 30 years to 80 years
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.
Interventions
BIOLOGICAL
Renal Autologous Cell Therapy (REACT)
Conditions
Diabetic Kidney DiseaseChronic Kidney Diseases
Locations
Boise Kidney & Hypertension Institute
Meridian, Idaho 83642
United States