drugset / Trial / NCT05018416

Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

Phase 2 Completed 53 enrolled Prokidney

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT) / rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease (CKD).

Timeline

Start: 2021-07-27
Primary completion: 2025-05-20
Completion: 2025-05-20

Outcome

Mixed primary results

release “We are very encouraged by the REGEN-007 topline results that demonstrated a robust improvement in eGFR slope following treatment with rilparencel in Group 1.” prokidney.com ↗

release “This 4.6 mL/min/1.73m2 per year difference was statistically significant (p<0.001) and clinically meaningful.” prokidney.com ↗

release “This difference was not statistically significant (p=0.085) but suggests evidence of a dose response.” prokidney.com ↗

release “On July 8, 2025, ProKidney announced statistically and clinically significant topline results from the Phase 2 REGEN-007 study” prokidney.com ↗

release “The primary efficacy endpoint was change in eGFR slope from the pre-injection period to the period after the last injection analyzed using a linear mixed model.” prokidney.com ↗

release “In Group 1 (n=24), bilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m2 improvement in the annual decline in eGFR slope” prokidney.com ↗

release “Group 2 (n=25) tested an exploratory dosing regimen that resulted in 10 of 25 (40%) patients receiving only one rilparencel injection” prokidney.com ↗

release “following treatment with rilparencel, the annual decline in eGFR slope improved by 1.7 mL/min/1.73m2, or 50%; this improvement was not statistically significant (p=0.085)” prokidney.com ↗

Publications

Cizman B, Butler EL, Stavas J, Prakash R, Saad T, Silva A, Wooldridge T, Aqeel A, Yan H, Barysauskas CM, Culleton B. A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Jan 2;21(5):744-53. doi: 10.2215/CJN.0000000969. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rilparencel	Cell therapy	—	Other