CAKUT, Chronic Kidney Diseases, Diabetic Kidney Disease
Conditions
Keywords
REACT, CAKUT, DKD
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.
Interventions
BIOLOGICALRenal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)
Sponsors
Prokidney
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period. 2. The participant is male or female, 30 to 80 years of age on the date of informed consent. 3. 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. 4. The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.
Exclusion criteria
1. The participant has a history of renal transplantation. 2. The participant has received dialysis for more than 30 days. 3. The participant has received any other investigational products after completion of REACT injections within 3 months of screening. 4. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 1. Biopsy Related SAEs 2. Injection Procedure Related SAEs 3. Investigational Product Related SAEs 4. Treatment-Emergent SAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed