Rilparencel leads to kidney function stabilisation in chronic kidney disease and type 2 diabetes

Rilparencel, a cell-based therapy using ex vivo cultured expansion of autologous cells from percutaneous kidney biopsies, showed a slowing of eGFR decline in participants with stage 3–4 chronic kidney disease (CKD) and comorbid diabetes in the phase 2 REACT trial.

The current multicentre, open-label, phase 2 REACT trial (NCT02836574) included participants aged 30–80 years, with type 2 diabetes and stage 3–4 CKD (eGFR between ≥20 and <50 mL/min/1.73 m²), and without renal dialysis. Following baseline biopsy, participants were randomised to an active cohort (receiving 2 rilparencel doses immediately, n=39) or to a deferred group (receiving 2 rilparencel injections 12 months after baseline, n=34). The time between rilparencel doses was 3–6 months. All participants received background standard-of-care therapy. The primary efficacy endpoint was a change in kidney function determined by serial eGFR measurements [1].

The deferred cohort served as the control group for the active cohort for the initial 12 months of the trial. At 12 months after baseline and before the deferred start of rilparencel, the mean eGFR reduction was -3.7 mL/min/1.73 m² in the active group compared with -4.3 mL/min/1.73 m² in the deferred group (P<0.05). Upon the start of rilparencel, the deferred group’s eGFR stabilised, with a mean decline of -1.1 mL/min/1.73 m². The significant differences were maintained in a post-hoc analysis in participants with eGFR < 30 ml/min/1.73 m². In total, 3 serious adverse events (AEs) related to the biopsy and 10 AEs related to study injections were observed and none of them were linked to rilparencel. Non-serious AEs, potentially linked to rilparencel, included kidney fibrosis and indeterminate renal vessel occlusion/vasospasm.

“Our data suggest that rilparencel may preserve kidney function in patients with type 2 diabetes and moderate-to-severe chronic kidney disease”, said Dr Joseph Stavas (ProKidney LLC, Winston-Salem, NC, USA). “Rilparencel is under further investigation in an ongoing global phase 3 study program.”

1. Gerber D, et al. Rilparencel renal autologous cell therapy for patients with Stage 3-4 CKD and type 2 diabetes: Results from a phase 2 clinical trial. Abstract #8, ERA 2024, 23–26 May, Stockholm, Sweden.

Medical writing support was provided by Mihai Surducan, PhD.

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Posted on 20 June 202424 June 2024