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
- Chronic Kidney Disease
- Diabetic Kidney Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Renal Autologous Cell Therapy (REACT) — BIOLOGICALNo 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 REACTParticipants 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boise Kidney & Hypertension Institute | Meridian | Idaho | 83642 | - |
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