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).
NCT04115345 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2023-12-21
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)
Conditions
- Chronic Kidney Disease
- Congenital Anomalies of Kidney and Urinary Tract
Interventions
- BIOLOGICAL
-
Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)
Sponsors & Collaborators
-
CTI Clinical Trial and Consulting Services
collaborator OTHER -
Prokidney
lead INDUSTRY
Principal Investigators
-
Study Director · Prokidney
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-13
- Primary Completion
- 2023-01-31
- Completion
- 2023-01-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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