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).

Completed · Phase 1

Conditions studied: Chronic Kidney Disease, Congenital Anomalies of Kidney and Urinary Tract

In brief

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)

Key facts

Study ID

NCT04115345

Run by

Prokidney

People needed

6

Starts

2019-08-13

Expected to finish

2023-01-31

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States
• Boise Kidney & Hypertension Institute — Meridian, Idaho, United States
• Hackensack Meridian Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Mt. Sinai Hospital — New York, New York, United States
• University of North Carolina- Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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