REACT for Chronic Kidney Disease in Diabetics

Recruiting at 4 trial locations

Overseen By Rachita Prakash, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Prokidney

Disqualifiers: Renal transplant, Hypertension, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months (+60 days) for Cohort 1; variable for Cohort 2 based on trigger

53 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing REACT injections, which are given directly into the kidneys, to help patients with diabetes and chronic kidney disease. The goal is to see if these injections can improve kidney function.

Research Team

Catherine Taylor

Principal Investigator

Prokidney

Eligibility Criteria

This trial is for men and women aged 30-80 with Type 1 or Type 2 Diabetes and Chronic Kidney Disease (CKD). Participants should have diabetic nephropathy, an eGFR of 20-50 mL/min/1.73m² without needing dialysis, controlled diabetes, and HbA1c levels below 10%. Excluded are those with renal transplants, uncontrolled blood pressure despite medication, or hemoglobin levels under 10 g/dL not improved by standard treatments.

Inclusion Criteria

My kidney problems are due to diabetes.

My kidney function is low but I don't need dialysis.

Your HbA1c level is less than 10%.

Exclusion Criteria

Your average blood pressure is too high during the screening.

Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.

I have had a kidney transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys

3 months (+60 days) for Cohort 1; variable for Cohort 2 based on trigger

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months after the final REACT injection

Long-term monitoring

Participants are monitored for changes in renal function and other health parameters

Thru month 34

Treatment Details

Interventions

• REACT®

Trial Overview The study tests the safety and effectiveness of Renal Autologous Cell Therapy (REACT), which involves up to two injections into the kidneys. It aims to see if this can slow down kidney function decline in people with either Type 1 or Type 2 Diabetes who also have CKD.

Participant Groups

Group I: 2 REACT injections Experimental Treatment 1 Intervention

Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).

Group II: 1 REACT Injection Experimental Treatment 1 Intervention

Cohort 2 subjects will receive 1 REACT injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT injection into the contralateral kidney.

Who Is Running the Clinical Trial?

Prokidney

Lead Sponsor

Trials

10

Recruited

880+