What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, particularly in patients with chronic kidney disease, include GLP-1 receptor agonists and SGLT2 inhibitors. GLP-1 receptor agonists, such as liraglutide and dulaglutide, can cause gastrointestinal side effects like nausea, vomiting, and diarrhea. SGLT2 inhibitors, such as empagliflozin and canagliflozin, are associated with an increased risk of genital and urinary tract infections, and in some cases, a temporary decrease in kidney function. Glucocorticoids, used in some kidney disease treatments, can lead to serious adverse events like severe infections and hospitalization, especially at higher doses.

What prior FDA approvals exist?

The REACT trial is exploring a regenerative medicine approach to improve kidney function in Type 2 Diabetes patients with chronic kidney disease (CKD). While there are no FDA-approved treatments exactly like REACT, several antihyperglycemic agents have shown benefits for kidney function. Notably, SGLT2 inhibitors such as canagliflozin, empagliflozin, and dapagliflozin have been approved by the FDA and have demonstrated efficacy in reducing the progression of CKD in patients with Type 2 Diabetes. These drugs not only help in glycemic control but also offer renal protection, making them relevant to the goals of the REACT trial.

What other types of research exist?

Promising novel alternatives to REACT for Type 2 Diabetes patients with CKD include the combination of nanotechnology with stem cell or gene therapy for kidney repair, and the use of SGLT2 inhibitors (e.g., empagliflozin, canagliflozin, dapagliflozin) and GLP-1 receptor agonists (e.g., liraglutide, semaglutide, dulaglutide) which have shown cardiorenal benefits.

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Cell Therapy

REACT for Type 2 Diabetes with Chronic Kidney Disease

Phase 2

Waitlist Available

Research Sponsored by Prokidney

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject has an established diagnosis of T2DM.

The subject is male or female, 30 to 80 years of age on the date of informed consent.

Must not have

The subject has a history of type 1 diabetes mellitus.

The subject has a history of renal transplantation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 24 months following last react injection for active arm and at least 12 months following last react injection for the deferred arm

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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%.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions at the injection site or complications related to the procedure since cells are injected into the kidney using a needle through the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have been diagnosed with type 2 diabetes.

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You are between 30 and 80 years old when you agree to take part in the study.

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You have been diagnosed with kidney disease caused by diabetes.

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You have a kidney condition with a certain level of eGFR, but you don't need dialysis yet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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You have had a kidney transplant in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 24 months following last react injection for active arm and at least 12 months following last react injection for the deferred arm

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 24 months following last react injection for active arm and at least 12 months following last react injection for the deferred arm

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 24 months following last react injection for active arm and at least 12 months following last react injection for the deferred arm for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Renal Function

Secondary study objectives

Treatment emergent adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate TreatmentExperimental Treatment2 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 TreatmentActive Control2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Renal Autologous Cell Therapy (REACT)

2016

Completed Phase 2

~100

Renal Biopsy

2016

Completed Phase 2

~200

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes (T2D) include metformin, which reduces glucose production in the liver and improves insulin sensitivity; SGLT2 inhibitors, which prevent glucose reabsorption in the kidneys, leading to glucose excretion in urine; and GLP-1 receptor agonists, which enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. These treatments are crucial for T2D patients as they help manage blood glucose levels, reduce the risk of complications, and improve overall metabolic health. In the context of the REACT trial, regenerative approaches aim to repair kidney damage and improve function, potentially offering a complementary strategy to traditional pharmacotherapy by addressing underlying kidney issues directly.

Pharmacotherapy of type 2 diabetes: An update and future directions.