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

Part of paid clinical trials in Meridian, Idaho.

Sponsor
Prokidney
Study ID
NCT06790498
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Renal Autologous Cell Therapy (REACT) — BIOLOGICAL
    No interventions in this trial

Study Details

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.

Key Dates

Start date
Nov 23, 2023
Status verified
Jan 2025
Primary completion
May 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
50 participants (estimated)

Arms

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

Primary Outcome Measure

Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies. [ Time Frame: 60 months from completion of parent protocol EOS Visit ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boise Kidney & Hypertension InstituteMeridianIdaho83642-

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