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

A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies REGEN-006, REGEN-007, and REGEN-015 (REGEN-008S2)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetic Kidney Disease; Chronic Kidney Disease
• Intervention / Treatment: Biological: Renal Autologous Cell Therapy (REACT)

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Boise Kidney & Hypertension Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Kidney Disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CKD patients previously treated with REACT; Participants Exposed to Renal Autologous Cell Therapy from studies REGEN-007, REGEN-006, REGEN-015 (REGEN-008S2).	Biological: Renal Autologous Cell Therapy (REACT); No interventions in this trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 months from completion of parent protocol EOS Visit

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prokidney
• Investigators: Study Director: Study Director, Prokidney

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Diabetes Mellitus; Diabetes Complications; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies
• Other Study ID Numbers: REGEN-008S2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No