Trials / Terminated
TerminatedNCT05694169
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Prokidney · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.
Detailed description
A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Renal Autologous Cell Therapy (REACT) | Autologous selected renal cells (SRC) |
Timeline
- Start date
- 2023-07-11
- Primary completion
- 2024-03-19
- Completion
- 2024-05-13
- First posted
- 2023-01-23
- Last updated
- 2025-02-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05694169. Inclusion in this directory is not an endorsement.