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NCT04115345 · ClinicalTrials.gov registry record · Phase 1
A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).
A Phase 1 study, sponsored by Prokidney.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04115345: Completed Phase 1 study, sponsored by Prokidney.
NCT04115345 is a Phase 1 study that has completed, run by Prokidney. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115345, a Phase 1 study, has completed, sponsored by Prokidney.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)
Primary Outcome
The primary objective is to assess the safety and optimal delivery of Renal Autologous Cell Therapy (REACT) injected at one site in a recipient kidney as measured by procedure- and/or product related adverse events (AEs) through 18 months post-treatment.
Interventions
- BIOLOGICAL Renal Autologous Cell Therapy (REACT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-08-13 |
| Est. Completion | 2023-01-31 |
| Phase | Phase 1 |
What the finished NCT04115345 record still lists
NCT04115345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Renal Autologous Cell Therapy (REACT) is the first listed.
NCT04115345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04115345 about?
NCT04115345 is a clinical study titled "A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).". A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)
What is the current status of trial NCT04115345?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2019-08-13. Estimated completion is 2023-01-31.
What interventions are being tested in trial NCT04115345?
The interventions under investigation include: Renal Autologous Cell Therapy (REACT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04115345?
This trial is sponsored by Prokidney, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04115345's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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