Status:
COMPLETED
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).
Lead Sponsor:
Prokidney
Collaborating Sponsors:
CTI Clinical Trial and Consulting Services
Conditions:
Chronic Kidney Disease
Congenital Anomalies of Kidney and Urinary Tract
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 Urina...
Detailed Description
It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific rationale, base...
Eligibility Criteria
Inclusion
- The patient is male or female, 18 to 65 years of age on the date of informed consent.
- The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction.
- The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis.
- The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s).
Exclusion
- The patient has a history of renal transplantation.
- The patient has a diagnosis of hydronephrosis, SFU Grade 4 or 5.
- The patient has an uncorrected VUR Grade 5.
- The patient has a diffuse cortical thickness throughout the kidney measuring \< 5 mm on MRI that prevents safe cortical biopsy.
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04115345
Start Date
August 13 2019
End Date
January 31 2023
Last Update
December 21 2023
Active Locations (5)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322
2
Boise Kidney & Hypertension Institute
Meridian, Idaho, United States, 83642
3
Hackensack Meridian Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
4
Mt. Sinai Hospital
New York, New York, United States, 45246