What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) include pharmacologic agents like ACE inhibitors and ARBs, which can cause hyperkalemia and hypotension. Immunosuppressive therapies, such as glucocorticoids and calcineurin inhibitors, are associated with increased risks of infections, impaired glucose tolerance, and weight gain. Experimental regenerative therapies, like REACT injections, aim to improve kidney function but may carry risks of local and systemic infections, immune reactions, and procedural complications. Further studies are needed to fully understand the safety profile of these regenerative treatments.

What prior FDA approvals exist?

There is no specific mention of FDA-approved regenerative or reparative therapies for Chronic Kidney Disease (CKD) similar to the REACT trial's renal autologous cell therapy in the provided context. Generally, FDA-approved treatments for CKD focus on managing symptoms and slowing disease progression, including medications like ACE inhibitors, ARBs, and treatments for complications such as anemia and bone disease. Innovative therapies like the ones being studied in the REACT trial represent a new frontier in CKD treatment, aiming to repair or regenerate kidney tissue to improve function.

What other types of research exist?

Promising novel alternatives to REACT injections for CKD patients include: 1) Stem cell therapy, particularly the use of mesenchymal stem cells (MSCs), which have shown potential in promoting kidney repair and reducing inflammation. 2) Gene therapy approaches targeting specific genetic pathways involved in kidney damage and repair. 3) Advanced cell-based therapies, such as the use of allogeneic cardiosphere-derived cells (CDCs), which have demonstrated anti-inflammatory effects and potential in reducing disease progression in other conditions. These therapies are still under investigation and require further clinical trials to confirm their efficacy and safety.

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Cell Therapy

REACT for Chronic Kidney Disease in Diabetics

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 a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).

The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Must not have

The subject has a history of renal transplantation.

The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up thru month 34

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include reactions at the injection site like pain or swelling, potential infection risk from injections, allergic responses to therapy components, and unforeseen impacts on kidney function.

Eligibility Criteria

Inclusion Criteria

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

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My kidney problems are due to diabetes.

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My kidney function is low but I don't need dialysis.

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I have been diagnosed with type 1 or type 2 diabetes and it is under control.

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I am between 30 and 80 years old.

Exclusion Criteria

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

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I have had a kidney transplant.

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My hemoglobin is below 10 g/dL and treatments for anemia due to kidney disease haven't worked.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ thru month 34

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~thru month 34

This trial's timeline: 3 weeks for screening, Varies for treatment, and thru month 34 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Changes from Baseline in serial measurements of UACR

Changes from Baseline in serial measurements of blood urea nitrogen

Changes from Baseline in serial measurements of cystatin C

+22 more

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

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Renal Autologous Cell Therapy (REACT)

2016

Completed Phase 2

~100

0 / 6Eligibility 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 Chronic Kidney Disease (CKD) include regenerative or reparative therapies such as autologous cell therapy and extracellular vesicle (EV)-based therapy. These treatments work by promoting tissue repair, reducing inflammation, and preventing fibrosis in the kidneys. Autologous cell therapy involves injecting a patient's own cells to regenerate damaged kidney tissue, while EV-based therapy uses vesicles derived from stem cells to deliver reparative signals to injured areas. These mechanisms are crucial for CKD patients as they offer the potential to restore kidney function, slow disease progression, and improve overall quality of life.

The Nephroprotective Properties of Extracellular Vesicles in Experimental Models of Chronic Kidney Disease: a Systematic Review.Deleting Death and Dialysis: Conservative Care of Cardio-Vascular Risk and Kidney Function Loss in Chronic Kidney Disease (CKD).Established and Emerging Strategies in the Treatment of Chronic Kidney Disease.