53 Participants Needed

REACT for Chronic Kidney Disease in Diabetics

Recruiting at 4 trial locations
MC
NM
BO
TD
PY
RP
Overseen ByRachita Prakash, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Prokidney
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

CT

Catherine Taylor

Principal Investigator

Prokidney

Are You a Good Fit for This Trial?

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%.
See 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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Prokidney

Lead Sponsor

Trials
10
Recruited
880+
Unbiased ResultsWe believe in providing patients with all the options.
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