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).

Chronic Kidney Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115345
• Other study ID #: REGEN-004
• Status: Completed
• Phase: Phase 1
• Start date: August 13, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Prokidney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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, based on non-clinical studies, is that the biologically active component of REACT (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney Disease (CKD) by augmenting renal structure and function. As a result, the more cells that can be infused, the greater the potential improvement in renal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. The patient is male or female, 18 to 65 years of age on the date of informed consent.

2. The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction.

3. The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis.

4. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s).

Exclusion Criteria:

1. The patient has a history of renal transplantation.

2. The patient has a diagnosis of hydronephrosis, SFU Grade 4 or 5.

3. The patient has an uncorrected VUR Grade 5.

4. The patient has a diffuse cortical thickness throughout the kidney measuring < 5 mm on MRI that prevents safe cortical biopsy.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Congenital Abnormalities
• Congenital Anomalies of Kidney and Urinary Tract
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Prokidney	CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess change in eGFR and observe incidence of renal-specific procedure and/or product related adverse events (AEs) through 18 months following two Renal Autologous Cell Therapy (REACT) injections [Safety].	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.	18 months following last REACT injection
Secondary	Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT).	The number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT) will be observed utilizing renal-specific laboratory assessments.	18 months following last REACT injection