REACT for Chronic Kidney Disease in Diabetics

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called REACT® to determine its potential benefits for individuals with chronic kidney disease (CKD) caused by diabetes. The study tests the safety and effectiveness of REACT® injections in slowing kidney function decline. Participants are divided into two groups: one group receives two injections, while the other starts with one and may receive a second based on specific triggers. This trial may suit individuals with type 1 or type 2 diabetes who have kidney issues, do not require dialysis, and have an HbA1c level below 10%. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that REACT® is likely to be safe for humans?

Research has shown that REACT injections have been tested for safety in treating kidney problems. In one study, patients received up to two injections directly into their kidneys, and most patients handled the injections well. The study did not report any serious side effects, though some people might experience mild side effects, as with any treatment.

This trial is in Phase 2, indicating it is still in the early stages of testing but has passed initial safety checks. While the treatment appears safe so far, more research is needed to confirm its safety for a larger group of people. Prospective participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic kidney disease?

Researchers are excited about REACT® for chronic kidney disease in diabetics because it offers a new approach by directly injecting into the kidneys. Unlike standard treatments like ACE inhibitors or ARBs that primarily work by controlling blood pressure and slowing disease progression, REACT® involves injections that could potentially repair kidney damage. This method targets the kidneys more directly and might help improve kidney function more effectively in diabetic patients. Additionally, the flexibility in dosing—either one or two injections based on patient response—allows for personalized treatment, which is a novel approach compared to current options.

What evidence suggests that REACT® might be an effective treatment for chronic kidney disease in diabetics?

Research has shown that REACT® injections might improve kidney function in individuals with diabetic kidney disease (DKD). In this trial, participants will receive either two REACT injections or one, with the possibility of a second if certain conditions are met. Studies have found that these treatments could repair damaged nephrons, which filter waste in the kidneys. This might slow the progression of kidney disease. Early results suggest that these injections can stabilize or even improve kidney function, reducing the risk of severe kidney disease. Although more research is needed, initial evidence supports the potential benefits of REACT® for treating chronic kidney disease in people with diabetes. ^{1 2 5 6 7}

Who Is on the Research Team?

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%.

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 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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11151988/

Rilparencel (Renal Autologous Cell Therapy-REACT®) for ... This multicenter phase 2 RCT is designed to investigate the efficacy and safety of rilparencel with bilateral kidney dosing and compare two injection schedules.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05018416

NCT05018416 | Study of Renal Autologous Cell Therapy ... The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468024923004795

WCN23-0428 RENAL AUTOLOGOUS CELL THERAPY ... REACT™ cell-based therapy has the potential to effect nephron structure and function by stabilizing or improving DKD progression and its comorbidities. Current ...

4. academic.oup.com academic.oup.com/ndt/article/38/Supplement_1/gfad063c_5734/7196478

#5734 RENAL AUTOLOGOUS CELL THERAPY (REACT ... Well-based therapies may repair diseased nephrons and stabilize and enhance kidney function to delay the onset of end-stage kidney disease and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02836574

NCT02836574 | A Study of Renal Autologous Cell Therapy ... To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05286853

A Study of Renal Autologous Cell Therapy (REACT) in ... The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered ...

7. investors.prokidney.com investors.prokidney.com/news-releases/news-release-details/prokidney-reports-statistically-and-clinically-significant

Releases Details In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m2 in the pre-injection period versus -1.7 ...