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

Prokidney

Status: Enrolling

Conditions: Chronic Kidney Diseases; Diabetic Kidney Disease

Treatments: Biological: Renal Autologous Cell Therapy (REACT)

Study type: Observational

Funder types: Industry

Identifiers

NCT05918523

REGEN-008S1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

CKD patients previously treated with REACT

Description:

Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1).

Treatment:

Biological: Renal Autologous Cell Therapy (REACT)