REACT for Chronic Kidney Disease in Diabetics

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Prokidney

No Placebo Group

Prior Safety Data

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.

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%.

+2 more

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.

+1 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: 2 REACT injectionsExperimental Treatment1 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 InjectionExperimental Treatment1 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.