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

NCT06790498 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: REGEN-008S2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Kidney Disease; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

  60 months from completion of parent protocol EOS Visit

• Time from first injection to renal transplant

  60 months from completion of parent protocol EOS Visit

• 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.

  60 months from completion of parent protocol EOS Visit

Study Arms (1)

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)

Interventions

Renal Autologous Cell Therapy (REACT) BIOLOGICAL

No interventions in this trial

CKD patients previously treated with REACT

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Kidney Disease

You may qualify if:

• 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.

You may not qualify if:

• Participant did not receive REACT in a previous trial for the treatment of chronic kidney disease

Sponsors & Collaborators

• Prokidney: lead

Study Sites (1)

Boise Kidney & Hypertension Institute

Meridian, Idaho, 83642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Research samples (serum/plasma and/or urine) will be collected, frozen, and stored for the future research. Participating participants can opt out of long-term storage of their unused specimens during the informed consent process or at any time during the study.

MeSH Terms

Conditions

Diabetic Nephropathies; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Prokidney

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 24, 2025
• Study Start: November 23, 2023
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

US (1)