A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).

Recruiting at 4 trial locations

Overseen By Kyle West

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Prokidney

Disqualifiers: Renal transplantation, Hydronephrosis, VUR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 months

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment that uses a patient's own kidney cells to help repair their kidneys. It targets patients with a specific type of chronic kidney disease that doesn't respond well to usual treatments. The goal is to slow down the disease and improve kidney function.

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.

How is Renal Autologous Cell Therapy (REACT) different from other treatments for chronic kidney disease?

Renal Autologous Cell Therapy (REACT) is unique because it involves injecting a patient's own kidney cells directly into their kidneys to potentially delay or avoid the need for dialysis or kidney replacement. This approach is different from standard treatments, which typically focus on managing symptoms rather than repairing kidney function. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Renal Autologous Cell Therapy (REACT)?

Research suggests that Renal Autologous Cell Therapy (REACT) may help delay the progression of chronic kidney disease, especially in patients with diabetes-related kidney issues. Early trials indicate that this treatment could stabilize kidney function and potentially reduce the need for dialysis or kidney replacement. ^{1 2 3 4 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Prokidney

Are You a Good Fit for This Trial?

Inclusion Criteria

The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction.

The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis.

The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two planned Renal Autologous Cell Therapy (REACT) injections to evaluate the duration of effects

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Renal Autologous Cell Therapy (REACT)

How Is the Trial Designed?

Group I: Renal Autologous Cell Therapy (REACT) Experimental Treatment 1 Intervention

The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula. The participant will receive a second injection 6 months after the first injection into the same kidney.

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

The REACT trial is a phase II multicenter study involving 83 adults with type 2 diabetic kidney disease (T2DKD), aiming to assess the safety and efficacy of a novel renal autologous cell therapy delivered via direct kidney injection to improve renal function.

The study will measure changes in estimated glomerular filtration rates (eGFR) over 24 months, comparing an active treatment group receiving REACT injections to a deferred treatment group, with a focus on monitoring for any adverse events related to the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial Design. Stavas, J., Gerber, D., Coca, SG., et al.[2022]

The REACT trial, involving 5 adults with congenital anomalies of the kidney and urinary tract (CAKUT) and chronic kidney disease (CKD) stages 3 and 4, shows promising safety with no complications related to the cell acquisition or injection procedures.

Preliminary results suggest that Renal Autologous Cell Therapy may stabilize or improve renal function, potentially delaying the need for dialysis in patients with CAKUT-associated CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol and Baseline Data on Renal Autologous Cell Therapy Injection in Adults with Chronic Kidney Disease Secondary to Congenital Anomalies of the Kidney and Urinary Tract. Stavas, J., Diaz-Gonzalez de Ferris, M., Johns, A., et al.[2022]

The REACT trial, involving 10 adults with late-stage diabetic chronic kidney disease, demonstrated that autologous cell therapy is safe, with no cell-related adverse events reported and only minor procedure-related complications.

Participants experienced a delay in the need for dialysis by an average of 16 months, and 20% of patients showed stability in kidney function, suggesting that REACT may effectively stabilize renal function in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal Autologous Cell Therapy in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis. Stavas, J., Thajudeen, B., Coca, S., et al.[2023]

In a study involving 22 adults with advanced type 2 diabetes-related chronic kidney disease (D-CKD), injections of autologous selected renal cells (SRCs) significantly improved the annualized estimated glomerular filtration rate (eGFR) slope from -4.63 to -1.69 ml/min per 1.73 m² per year, indicating a stabilization of kidney function after treatment.

The analysis of SRCs revealed cell markers associated with kidney development, suggesting that these cells may play a role in halting the progression of D-CKD, with no direct adverse effects linked to the injections or the REACT product.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal Autologous Cell Therapy to Stabilize Function in Diabetes-Related Chronic Kidney Disease: Corroboration of Mechanistic Action With Cell Marker Analysis. Stavas, J., Filler, G., Jain, D., et al.[2022]

The STEADFAST study is a first-in-human trial assessing the safety and efficacy of TX200-TR101, a novel CAR-Treg therapy, in up to 15 living-donor renal transplant recipients, with a follow-up period of 84 weeks.

TX200-TR101 aims to enhance immunologic tolerance and prevent graft rejection in HLA-A∗02-mismatched kidney transplants, building on previous findings that Tregs are safe in renal transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Design: Human Leukocyte Antigen Class I Molecule A∗02-Chimeric Antigen Receptor Regulatory T Cells in Renal Transplantation. Schreeb, K., Culme-Seymour, E., Ridha, E., et al.[2022]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial Design. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Protocol and Baseline Data on Renal Autologous Cell Therapy Injection in Adults with Chronic Kidney Disease Secondary to Congenital Anomalies of the Kidney and Urinary Tract. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Renal Autologous Cell Therapy in Type 2 Diabetes with Late Stage 4 Diabetes-Related Chronic Kidney Disease: Trial Design and Early Analysis. [2023]

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

Renal Autologous Cell Therapy to Stabilize Function in Diabetes-Related Chronic Kidney Disease: Corroboration of Mechanistic Action With Cell Marker Analysis. [2022]

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

Feasibility, long-term safety, and immune monitoring of regulatory T cell therapy in living donor kidney transplant recipients. [2023]

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

Study Design: Human Leukocyte Antigen Class I Molecule A∗02-Chimeric Antigen Receptor Regulatory T Cells in Renal Transplantation. [2022]