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

• Conditions: Diabetic Kidney Disease; Chronic Kidney Disease
• Interventions: Biological: Renal Autologous Cell Therapy (REACT)

• Registration Number: NCT06790498
• Lead Sponsor: Prokidney

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2023-11-23
• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2030-05-31
• Study Completion: 2030-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CKD patients previously treated with REACT	Renal Autologous Cell Therapy (REACT)	Participants Exposed to Renal Autologous Cell Therapy from studies REGEN-007, REGEN-006, REGEN-015 (REGEN-008S2).

Primary Outcome Measures

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

Name	Time	Method
Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.	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.
Time from first injection to chronic dialysis.	60 months from completion of parent protocol EOS Visit	Time from first injection to chronic dialysis
Time from first injection to a cardiovascular death.	60 months from completion of parent protocol EOS Visit	Time from first injection to a cardiovascular death.
Time from first injection to renal transplant	60 months from completion of parent protocol EOS Visit	Time from first injection to renal transplant
Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD) at Months 12, 24, 36, 48, and 60.	60 months from completion of parent protocol EOS Visit	Percent of participants who have the same or reduced 5-year risk of end stage renal
Time from first injection to a renal death.	60 months from completion of parent protocol EOS Visit	Time from first injection to a renal death.
Percent of participants who have the same or reduced 2-year risk of end stage renal disease at Months 12, 24, 36, 48, and 60.	60 months from completion of parent protocol EOS Visit	Percent of participants who have the same or reduced 2-year risk of end stage renal

Trial Locations

Locations (1)

Boise Kidney & Hypertension Institute; 🇺🇸 Meridian, Idaho, United States