A Study of Participants With Chronic Kidney Disease Previously Treated With REACT

Sponsor

Prokidney (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05694169

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Kidney Disease CAKUT Chronic Kidney Diseases	Biological: Renal Autologous Cell Therapy (REACT)	Phase 1

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 into contralateral kidneys separated by 3 months. All participants will be followed for 12 months post last supplemental REACT injection.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Renal Autologous Cell Therapy (REACT) Participants will receive 2 REACT injections into contralateral kidneys separated by 3 months. All participants will be followed for 12 months post last supplemental REACT injection.	Biological: Renal Autologous Cell Therapy (REACT) Autologous selected renal cells (SRC)

Arm

Intervention/Treatment

Experimental: Renal Autologous Cell Therapy (REACT)

Participants will receive 2 REACT injections into contralateral kidneys separated by 3 months. All participants will be followed for 12 months post last supplemental REACT injection.

Biological: Renal Autologous Cell Therapy (REACT)

Autologous selected renal cells (SRC)

Outcome Measures

Primary Outcome Measures

Primary Endpoints is as follows: [through 12 months after last supplemental injection]
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 [12 months after the last supplemental injection]
Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD)
Second Secondary Endpoint [12 months after the last supplemental injection]
Percent of participants who have the same or reduced 2-year risk of ESRD
Third Secondary Endpoint [12 months after the last supplemental injection]
Relative change from baseline in eGFR
Fourth Secondary Enpoint [12 months after the last supplemental injection]
Relative change from baseline in random urine microalbumin/urine creatinine ratio

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.