NCT05918523

A Long-Term Follow-Up Study of Participants Exposed to REACT

A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Prokidney · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Kidney Disease
• Chronic Kidney Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Renal Autologous Cell Therapy (REACT)	No interventions in this trial

Timeline

• Start date: 2023-12-11
• Primary completion: 2028-01-01
• Completion: 2028-03-01
• First posted: 2023-06-26
• Last updated: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study