REACT for Chronic Kidney Disease

Overseen By Tierney Daigle

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Prokidney

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antihypertensive medication, you must be on a stable regimen.

What data supports the idea that REACT for Chronic Kidney Disease is an effective treatment?

The available research does not provide specific data on the effectiveness of REACT for Chronic Kidney Disease. Instead, it focuses on treatments for lupus nephritis, a different condition. For example, autologous hematopoietic stem cell transplantation has shown promise in treating severe lupus nephritis, with some patients achieving long-term remission. However, this information does not directly support the effectiveness of REACT for Chronic Kidney Disease. ^{1 2 3 4 5}

What safety data exists for REACT treatment in chronic kidney disease?

Safety data for REACT treatment in chronic kidney disease is available from several clinical trials. A phase I trial (NCT04115345) focused on adults with congenital anomalies of the kidney and urinary tract, assessing safety and efficacy. A phase II multicenter trial evaluated safety and tolerability in adults with type 2 diabetic kidney disease, focusing on procedure, product administration, and renal-specific adverse events. Early results from these trials indicate that safety and tolerability are key objectives, with ongoing assessments of renal function following REACT administration. ^{6 7 8 9 10}

Is the treatment REACT a promising treatment for chronic kidney disease?

Yes, REACT is a promising treatment for chronic kidney disease. It uses special cells from the patient's own body to help improve kidney function and potentially delay the need for more serious treatments like dialysis. Early studies show it could help people with diabetes-related kidney problems and other kidney issues. ^{6 7 8 9 10}

Research Team

Study Director

Principal Investigator

Prokidney

Eligibility Criteria

This trial is for adults aged 30-80 with chronic kidney disease who've had REACT treatment before. They must have stable blood pressure, possibly managed by medication, and not need dialysis yet. People can't join if they've been on dialysis over 30 days, tried other new treatments recently, have very high protein in their urine, a past kidney transplant or low hemoglobin unresponsive to anemia treatment.

Inclusion Criteria

My blood pressure is stable, and if I take medication for it, the dose hasn't changed recently.

You have been in a previous trial for chronic kidney disease and finished all follow-up appointments.

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

Exclusion Criteria

I have been on dialysis for over a month.

The participant has received any other investigational products after completion of REACT injections within 3 months of screening.

Your urine test shows a very high level of albumin compared to creatinine.

Treatment Details

Interventions

• REACT (Cell Therapy)

Trial Overview The study tests the safety of additional REACT injections in people with chronic kidney disease who previously received this therapy. It aims to see how well patients tolerate more doses of the same treatment they had earlier.

Participant Groups

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

Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.

Who Is Running the Clinical Trial?

Prokidney

Lead Sponsor

Trials

10

Recruited

880+

Findings from Research

A multimodal intervention targeting urinary protein levels in 56 patients with heavy proteinuria led to a significantly slower decline in kidney function (GFR) compared to a matched historical group, with a median decline of -0.17 ml/min versus -0.56 ml/min over 4 years.

The intervention also resulted in a much lower incidence of end-stage renal disease (ESRD), with only 3.6% of patients reaching ESRD compared to 30.4% in the conventional therapy group, demonstrating the efficacy of proteinuria reduction in preserving kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of remission clinics in the longitudinal treatment of CKD. Ruggenenti, P., Perticucci, E., Cravedi, P., et al.[2022]

A 26-year-old patient with severe lupus nephritis and nephrotic syndrome achieved complete clinical and immunologic remission five years after undergoing autologous peripheral stem cell transplantation (ASCT).

The case highlights ASCT as a powerful treatment option for patients with severe systemic lupus erythematosus (SLE), demonstrating its potential efficacy in managing refractory cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term complete remission of severe nephrotic syndrome secondary to diffuse global (IV-G) lupus nephritis following autologous, haematopoietic peripheral stem (CD34+) cell transplantation. Marmont, AM., Gualandi, F., van Lint, MT., et al.[2017]

In a study of 178 lupus nephritis patients treated primarily with cyclophosphamide, 84.8% achieved a renal response, highlighting the efficacy of this treatment approach over 23 years.

Achieving a complete or partial renal response significantly improves both patient and kidney survival rates, with 15-year survival rates of 95% for complete responders compared to only 35% for nonresponders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppressive Treatment for Lupus Nephritis: Long-Term Results in 178 Patients. Zakharova, EV., Makarova, TA., Zvonova, EV., et al.[2018]

High-dose immunosuppression followed by autologous haematopoietic stem cell therapy can lead to major clinical responses in about 65% of systemic lupus erythematosus (SLE) patients, with some experiencing durable effects for several years.

While earlier studies reported procedure-related mortality rates of up to 12%, recent larger studies show this has decreased to less than 5%, indicating improved safety in newer transplantation regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood stem cells as therapy for severe lupus. Illei, GG., Pavletic, SZ.[2019]

Autologous hematopoietic cell transplantation (ASCT) showed promising long-term outcomes for patients with refractory lupus nephritis (LN), with 90% renal survival and 100% overall survival over a 10-year follow-up period for the 20 patients studied.

Eighteen out of 20 patients achieved complete remission after ASCT, indicating that this treatment can effectively improve immunologic homeostasis in refractory LN, although a relapse rate of 45% was observed, necessitating further management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of autologous peripheral blood hematopoietic stem cell transplantation for refractory lupus nephritis-a series study of 20 patients. Yang, L., Ren, G., Chen, W., 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]

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]

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]

References

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

Role of remission clinics in the longitudinal treatment of CKD. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Long term complete remission of severe nephrotic syndrome secondary to diffuse global (IV-G) lupus nephritis following autologous, haematopoietic peripheral stem (CD34+) cell transplantation. [2017]

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

Immunosuppressive Treatment for Lupus Nephritis: Long-Term Results in 178 Patients. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Blood stem cells as therapy for severe lupus. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up of autologous peripheral blood hematopoietic stem cell transplantation for refractory lupus nephritis-a series study of 20 patients. [2022]

6. 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]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. 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]

9. 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]

10. 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]