Back to resultsA 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).
Primary Purpose
Chronic Kidney Disease, Congenital Anomalies of Kidney and Urinary Tract
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Renal Autologous Cell Therapy (REACT)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Emory University Hospital
- Boise Kidney & Hypertension Institute
- Hackensack Meridian Jersey Shore University Medical Center
- Mt. Sinai Hospital
- University of North Carolina- Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Renal Autologous Cell Therapy (REACT)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04115345
First Posted
October 2, 2019
Last Updated
August 28, 2023
Sponsor
Prokidney
Collaborators
CTI Clinical Trial and Consulting Services
1. Study Identification
Unique Protocol Identification Number
NCT04115345
Brief Title
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).
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prokidney
Collaborators
CTI Clinical Trial and Consulting Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Congenital Anomalies of Kidney and Urinary Tract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal Autologous Cell Therapy (REACT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Renal Autologous Cell Therapy (REACT)
Intervention Description
Autologous selected renal cells (SRC)
Primary Outcome Measure Information:
Title
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].
Description
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.
Time Frame
18 months following last REACT injection
Secondary Outcome Measure Information:
Title
Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT).
Description
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.
Time Frame
18 months following last REACT injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Johns
Organizational Affiliation
Prokidney
Official's Role
Study Director
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Boise Kidney & Hypertension Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Hackensack Meridian Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
45246
Country
United States
Facility Name
University of North Carolina- Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33647913
Citation
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.
Results Reference
derived
Learn more about this trial
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).
We'll reach out to this number within 24 hrs