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 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: REGEN-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

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 Urinary Tract (CAKUT) (REGEN-004)

Conditions

Chronic Kidney Disease; Congenital Anomalies of Kidney and Urinary Tract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT).

  18 months following last REACT injection

Study Arms (1)

Renal Autologous Cell Therapy (REACT)

EXPERIMENTAL

The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula. The participant will receive a second injection 6 months after the first injection into the same kidney.

Biological: Renal Autologous Cell Therapy (REACT)

Interventions

Renal Autologous Cell Therapy (REACT) BIOLOGICAL

Autologous selected renal cells (SRC)

Renal Autologous Cell Therapy (REACT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Prokidney: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (5)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Boise Kidney & Hypertension Institute

Meridian, Idaho, 83642, United States

Location

Hackensack Meridian Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Mt. Sinai Hospital

New York, New York, 45246, United States

Location

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Stavas J, Diaz-Gonzalez de Ferris M, Johns A, Jain D, Bertram T. Protocol and Baseline Data on Renal Autologous Cell Therapy Injection in Adults with Chronic Kidney Disease Secondary to Congenital Anomalies of the Kidney and Urinary Tract. Blood Purif. 2021;50(4-5):678-683. doi: 10.1159/000512586. Epub 2021 Mar 1.

  PMID: 33647913 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cakut

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Prokidney

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: August 13, 2019
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)