REACT for Type 2 Diabetes with Chronic Kidney Disease

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

83 Participants Needed

Trial Summary

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 the REACT treatment generally safe for humans?

There is no specific safety data available for REACT or its other names, but caution is advised with similar treatments like glucagon-like peptide 1 receptor agonists (GLP-1 RAs) in patients with chronic kidney disease, as they have been associated with kidney issues in some cases. ^{1 2 3 4 5}

How is the REACT treatment different from other treatments for type 2 diabetes with chronic kidney disease?

The REACT treatment is unique because it involves using a patient's own cells (autologous cell therapy) to potentially improve kidney function, which is different from standard drug treatments that typically focus on controlling blood sugar and blood pressure. ^{3 6 7 8 9}

What is the purpose of this trial?

This trial tests a new treatment where patients with Type 2 Diabetes and Chronic Kidney Disease receive injections made from their own kidney cells to help repair kidney damage.

Research Team

Brian Johnston

Principal Investigator

CTI

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Immediate 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: Delayed 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+

Findings from Research

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Sodium-glucose co-transporter 2 inhibitors & glucagon-like peptide-1 receptor agonists, efficacy & safety in diabetic kidney transplant recipients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Acute Kidney Injury Associated With Semaglutide. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide 1 receptor agonist (GLP-1 RA): long-term effect on kidney function in patients with type 2 diabetes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Review of Newer Antidiabetic Agents for Diabetes Management in Kidney Transplant Recipients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

New Glucose-Lowering Agents for Diabetic Kidney Disease. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Dialysis therapy of terminal uraemia in insulin-requiring diabetic patients. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 receptor agonists use for type 2 diabetes mellitus in end-stage renal disease. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Importance of Early Screening and Diagnosis of Chronic Kidney Disease in Patients with Type 2 Diabetes. [2021]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Cardiorenal Protection in Diabetic Kidney Disease. [2022]