REACT for Type 2 Diabetes with Chronic Kidney Disease

No longer recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Prokidney

Must be taking: Antihypertensives

Disqualifiers: Type 1 diabetes, Renal transplant, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called REACT (Renal Autologous Cell Therapy) for individuals with Type 2 Diabetes and Chronic Kidney Disease (CKD). The researchers aim to determine if two injections into the kidney can safely help manage these conditions. Participants will either receive the injections immediately or undergo standard care for a year before receiving the injections. The trial seeks individuals with Type 2 Diabetes and CKD who have kidney issues not requiring dialysis and maintain stable blood pressure. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have stable blood pressure and be on a stable anti-hypertensive medication regimen, suggesting you may continue those medications.

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

Research has shown that the treatment called REACT (Renal Autologous Cell Therapy) is likely safe for patients. Studies have found that REACT is generally well-tolerated when injected into the kidneys. Most participants did not experience serious side effects. Some had minor reactions, but these were manageable.

Early results also suggest that REACT may help stabilize kidney function in people with diabetes and advanced chronic kidney disease (CKD). This is encouraging for those considering joining a trial. Although more research is needed, the current data provides a positive view of the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 Diabetes and Chronic Kidney Disease?

Unlike the standard of care for Type 2 Diabetes with Chronic Kidney Disease, which often involves medications like metformin and insulin, REACT (Renal Autologous Cell Therapy) uses a groundbreaking approach by employing a patient's own cells to potentially repair kidney damage. This personalized therapy is injected directly, aiming to restore kidney function rather than just managing symptoms. Researchers are excited because this could lead to more durable and effective treatment outcomes, offering hope for improved kidney health and better quality of life for patients.

What evidence suggests that REACT might be an effective treatment for Type 2 Diabetes with Chronic Kidney Disease?

Research has shown that REACT, or Renal Autologous Cell Therapy, could help address kidney problems caused by Type 2 Diabetes and Chronic Kidney Disease. Early results suggest that this therapy might stabilize kidney function in affected individuals. In this trial, participants will be randomized into two groups: one receiving immediate REACT treatment and the other receiving deferred treatment. REACT uses the patient's own cells to potentially repair and support kidney health. Studies on REACT have shown promising signs of improving kidney health. This method leverages the body's natural healing ability to target damaged kidney tissues. ^{1 2 3 4 5}

Who Is on the Research Team?

Brian Johnston

Principal Investigator

CTI

Are You a Good Fit for This Trial?

This trial is for adults aged 30-80 with Type 2 Diabetes and Chronic Kidney Disease (CKD) not on dialysis, with an eGFR of 20-50 mL/min/1.73m². Participants must have stable blood pressure under control with medication, no history of type 1 diabetes or kidney transplants, hemoglobin levels above 9 g/dL, and HbA1c below 10%.

Inclusion Criteria

The subject is willing and able to provide signed informed consent.

Your kidney function has been measured at least twice, with the results taken at least 3 months apart or within the last 18 months to see how your kidney disease is progressing.

Your blood pressure is lower than 150/90.

Exclusion Criteria

The subject is currently receiving renal dialysis.

Your hemoglobin levels are lower than 9 g/dL before getting each REACT injection.

You have been diagnosed with type 1 diabetes in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 2 injections of REACT, either immediately or 12 months after kidney biopsy, with injections 6 months apart

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

23 months

Open-label extension

Participants are followed for an additional 36 months of long-term follow-up

36 months

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). Participants will receive up to two REACT injections six months apart directly into their kidneys to see if it helps CKD in those with Type 2 Diabetes.

How Is the Trial Designed?

Group I: Active Treatment Experimental Treatment 2 Interventions

Renal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.

Group II: Deferred Treatment Active Control 2 Interventions

Renal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.

REACT is already approved in United States, European Union for the following indications:

Approved in United States as REACT for:

• Moderate to severe diabetic kidney disease

Approved in European Union as REACT for:

• Moderate to severe diabetic kidney disease

Who Is Running the Clinical Trial?

Prokidney

Lead Sponsor

Trials

10

Recruited

880+

CTI Clinical Trial and Consulting Services

Collaborator

Trials

36

Recruited

3,700+

Published Research Related to This Trial

DPP-4 inhibitors and GLP-1 receptor agonists are considered safe and effective for managing diabetes in kidney transplant recipients, while SGLT2 inhibitors may pose risks such as urinary tract infections and a slight decrease in renal function.

SGLT2 inhibitors are less effective in kidney transplant recipients compared to non-transplant patients with type 2 diabetes, highlighting the need for careful selection of antidiabetic agents based on individual patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Newer Antidiabetic Agents for Diabetes Management in Kidney Transplant Recipients. Anderson, S., Cotiguala, L., Tischer, S., et al.[2021]

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/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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38423000/

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 ...

4. 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- ...

5. journals.lww.com journals.lww.com/10.1681/ASN.2024xk3ssn5d

Rilparencel Autologous Cell Therapy in Patients with... Interim findings suggest rilparencel can stabilize kidney function in patients with diabetes and advanced CKD.