Renal Autologous Cell Therapy for Chronic Kidney Disease

No longer recruiting at 5 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Renal Autologous Cell Therapy (REACT) for individuals with chronic kidney disease (CKD) caused by congenital anomalies in the kidney and urinary tract (CAKUT). The trial aims to assess the safety and potential effectiveness of this treatment. Suitable candidates have a history of corrected kidney or urinary tract issues, have stage III/IV CKD, and are not currently on dialysis. Participants will receive two injections of the treatment into their kidney over six months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that Renal Autologous Cell Therapy (REACT) is likely to be safe for humans?

Research shows that Renal Autologous Cell Therapy (REACT) is under careful study for its safety and effectiveness. In earlier studies, patients generally tolerated REACT well, and no serious safety issues emerged. This therapy uses a patient's own kidney cells, which might explain its good tolerance.

Other studies are examining REACT for conditions like diabetic kidney disease. These studies have shown promising results in protecting kidney function, with no major safety problems reported. It is important to note that this therapy remains in the early stages of testing. While the initial safety information is encouraging, further research is necessary to fully understand its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for chronic kidney disease (CKD) from congenital anomalies, which often include medications to manage symptoms and dialysis, Renal Autologous Cell Therapy (REACT) offers a new approach by using the patient's own cells. This therapy involves injecting these cells directly into the kidney, potentially encouraging repair and regeneration of kidney tissue. Researchers are excited about REACT because it targets the root cause of the damage, rather than just treating the symptoms, and it harnesses the body's natural healing processes, which could lead to more effective and long-lasting improvements.

What evidence suggests that Renal Autologous Cell Therapy (REACT) might be an effective treatment for Chronic Kidney Disease from CAKUT?

Research has shown that Renal Autologous Cell Therapy (REACT), the treatment under study in this trial, might improve kidney health in people with Chronic Kidney Disease (CKD) caused by birth defects in the kidneys and urinary tract. In lab studies, injecting special cells directly into the kidney improved both kidney function and appearance. Early results suggest that REACT could stabilize or even enhance kidney function in CKD, potentially delaying the need for dialysis. These studies offer hope that REACT could effectively improve kidney health in affected individuals. ^{1 2 3 6 7}

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11151988/

Rilparencel (Renal Autologous Cell Therapy-REACT®) for ... Nonclinical studies showed enriched epithelial cells injected directly into the kidney cortex improved survival, kidney function, and structure while ...

2. 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- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468024923004795

WCN23-0428 RENAL AUTOLOGOUS CELL THERAPY ... REACT™ cell-based therapy has the potential to effect nephron structure and function by stabilizing or improving DKD progression and its comorbidities. Current ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03270956

NCT03270956 | A Study of Autologous Renal ... A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease. ClinicalTrials.gov ID NCT03270956. Sponsor ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33647913/

Protocol and Baseline Data on Renal Autologous Cell ... Autologous cell therapy treatment has the potential to stabilize or improve renal function in CAKUT-associated CKD to delay or avert dialysis.

6. investors.prokidney.com investors.prokidney.com/news-releases/news-release-details/prokidney-announces-positive-interim-data-rmcl-002-phase-2

ProKidney Announces Positive Interim Data from RMCL ... Updated positive interim Phase 2 data demonstrate potential efficacy of REACT to preserve kidney function in moderate and high-risk diabetic CKD patients.

7. academic.oup.com academic.oup.com/ndt/article/38/Supplement_1/gfad063c_5734/7196478

#5734 RENAL AUTOLOGOUS CELL THERAPY (REACT ... Current phase II and III trials are underway to determine efficacy, safety, renal function-dependent dosing, and time to treatment with ...