Back to resultsA Study of Participants With Chronic Kidney Disease Previously Treated With REACT
Primary Purpose
Diabetic Kidney Disease, CAKUT, Chronic Kidney Diseases
Status
Recruiting
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 Diabetic Kidney Disease focused on measuring REACT, CAKUT, DKD
Eligibility Criteria
Inclusion Criteria: The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period. The participant is male or female, 30 to 80 years of age on the date of informed consent. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis. The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary. Exclusion Criteria: The participant has a history of renal transplantation. The participant has received dialysis for more than 30 days. The participant has received any other investigational products after completion of REACT injections within 3 months of screening. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.
Sites / Locations
- Boise kidney and Hypertension InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Renal Autologous Cell Therapy (REACT)
Arm Description
Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
Outcomes
Primary Outcome Measures
Primary Endpoints is as follows:
Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via:
Biopsy Related SAEs
Injection Procedure Related SAEs
Investigational Product Related SAEs
Treatment-Emergent SAEs.
Secondary Outcome Measures
First Secondary Endpoint
Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD)
Second Secondary Endpoint
Percent of participants who have the same or reduced 2-year risk of ESRD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05694169
Brief Title
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
Official Title
A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prokidney
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
The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.
Detailed Description
A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease, CAKUT, Chronic Kidney Diseases
Keywords
REACT, CAKUT, DKD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Renal Autologous Cell Therapy (REACT)
Arm Type
Experimental
Arm Description
Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.
Intervention Type
Biological
Intervention Name(s)
Renal Autologous Cell Therapy (REACT)
Intervention Description
Autologous selected renal cells (SRC)
Primary Outcome Measure Information:
Title
Primary Endpoints is as follows:
Description
Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via:
Biopsy Related SAEs
Injection Procedure Related SAEs
Investigational Product Related SAEs
Treatment-Emergent SAEs.
Time Frame
through 12 months after last supplemental injection
Secondary Outcome Measure Information:
Title
First Secondary Endpoint
Description
Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD)
Time Frame
12 months after the last supplemental injection
Title
Second Secondary Endpoint
Description
Percent of participants who have the same or reduced 2-year risk of ESRD
Time Frame
12 months after the last supplemental injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.
The participant is male or female, 30 to 80 years of age on the date of informed consent.
The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.
The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.
Exclusion Criteria:
The participant has a history of renal transplantation.
The participant has received dialysis for more than 30 days.
The participant has received any other investigational products after completion of REACT injections within 3 months of screening.
The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.
The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Lopez
Phone
+1 919 788 3124
Email
julie.lopez@iconplc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tierney Daigle
Phone
+1 336-448-2843
Email
tierney.daigle@prokidney.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Johns, MSHS
Organizational Affiliation
Prokidney
Official's Role
Study Director
Facility Information:
Facility Name
Boise kidney and Hypertension Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnold Silva, MD
Phone
208-846-8335
12. IPD Sharing Statement
Learn more about this trial
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
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