Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

N/AEnrolling By InvitationNCT06790498

Prokidney50 enrolled

Overview

The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.

This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) will be monitored for up to five years with alternating in clinic and phone visits.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetic Kidney Disease Chronic Kidney Disease

Interventions

Renal Autologous Cell Therapy (REACT)BIOLOGICAL

No interventions in this trial

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol. * The participant is willing and able to cooperate with all aspects of the protocol. * The participant is willing and able to provide signed informed consent. Exclusion Criteria: • Participant did not receive REACT in a previous trial for the treatment of chronic kidney disease

Locations (1)

Boise Kidney & Hypertension Institute

Meridian, Idaho, United States

Outcomes

Primary Outcomes

Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.

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.