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Kidney Week

Abstract: TH-PO169

Renal Autologous Cell Therapy (REACT) to Delay Dialysis in Advanced CKD

Session Information

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical

Authors

  • Stavas, Joseph, ProKidney, Raleigh, North Carolina, United States
  • Thajudeen, Bijin, Banner University Medical Center Tucson, Tucson, Arizona, United States
  • Coca, Steven G., Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Detwiler, Randal K., The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
  • Silva, Arnold L., Boise Kidney and Hypertension, Boise, Idaho, United States
  • Anderson, Johnna D., ProKidney, Raleigh, North Carolina, United States
  • Burgner, Anna Marie, Vanderbilt University Medical Center, Nashville, Tennessee, United States
Background

Few treatments delay CKD progression. Cell-based options may offer destination therapy to preserve kidney function and avoid/delay renal replacement therapy (RRT).

Methods

Adults with Type 2 diabetes (T2DKD) and eGFRs 14-20 ml/min/1.73m2 participated in a multisite, FDA-approved phase 2 open label single arm trial (NCT03270956). After a kidney biopsy and ex vivo cell expansion, 2 percutaneous injections of REACT into the renal cortex were performed ~6 months apart. Patients were followed for up to 24 months to end of study (EOS) after the last injection. Outcomes included estimated glomerular filtration rate (eGFR) slope change (mixed linear effects analysis), time to dialysis, and adverse events (AEs).

Results

Ten patients were enrolled: 8 White race, 3 Hispanics, 5 Women. The cohort's mean age was 58.3 ±5.0 years and BMI 35.20 ±8.4 kg/m2. Nine patients had two injections and selected parameters are displayed in Table 1. Median time to dialysis was 19.4 months (IQR 13.3-27.9) and two patients were alive and dialysis free at EOS. Pre-injection eGFR slope improved 2.9 and 3.5 ml/min/1.73m2/year post 1st and 2nd injections. AEs: Six patients progressed to sustained RRT, two deaths occurred without RRT due to COVID-19 pneumonia and diabetes complications with COVID-19. Biopsy-related AEs: 1 each hematoma (no transfusion) and AVF. Injection-related AEs: 6 small-moderate hematomas (no transfusions), 1 each: hematuria, perinephric fluid, anemia, fatigue, and pain. REACT-related AEs: none.

Conclusion

REACT was tolerated and preserved function to decelerate eGFR decline, suggesting a non-dialytic treatment option for T2DKD progressing to RRT. Phase 3 randomized controlled trials and safety monitoring are underway.

Table 1. Trial parameters
ParameterBaseline n=1012 months n=5EOS n=2
Serum Cr mg/dL3.62±0.74.46±1.04.33±1.9
eGFR ml/min/1.73m215.5±2.712.6±3.314.8±7.7
Phosphate mg/dL4.75±0.94.18±0.65.3±2.0
Potassium mEq/L5.19±0.54.65±0.34.7±0.7
Bicarbonate mEq/L19.24±2.519.22±2.318.50±5.9
Calcium mg/dL8.95±0.69.06±0.79.0±0.4
PTH ng/L220.9±126.3253.6±208.1297.3±301.0
Hemoglobin10.49±1.110.18±1.811.3±0.2
Kidney Function (eGFR slope change ml/min/1.73m2/year)
TimeframePatients (n)eGFR slope (SE)
Pre-injection10-6.3 (1.29)
Post-1st injection10-3.4 (0.56)
Post-2nd injection9-2.8 (1.01)

Funding

  • Commercial Support – ProKidney