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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Diseases, Diabetic Kidney Disease, CAKUT

Intervention / Treatment
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* Biological: Renal Autologous Cell Therapy (REACT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Autologous Cell Therapy (REACT)<br>Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection. | Biological: Renal Autologous Cell Therapy (REACT)<br>* Autologous selected renal cells (SRC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through 12 months after last supplemental injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Secondary Endpoint | Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD) | 12 months after the last supplemental injection | 
| Second Secondary Endpoint | Percent of participants who have the same or reduced 2-year risk of ESRD | 12 months after the last supplemental injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REACT, CAKUT, DKD