A Phase 2 interventional study of Renal Autologous Cell Therapy (REACT) and Renal Biopsy in Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Prokidney. Completed at 16 sites in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Prokidney · Phase 2, Interventional, and Treatment
To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).
Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection.
Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 83 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Prokidney is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Study Part 1:
Exclusion Criteria for Study Part 1:
Inclusion Criteria for Study Part 2:
Exclusion Criteria for Study Part 2:
1. The subject is currently receiving renal dialysis.
Renal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Biological: Renal Autologous Cell Therapy (REACT) · Procedure: Renal Biopsy
Renal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.
Biological: Renal Autologous Cell Therapy (REACT) · Procedure: Renal Biopsy
Autologous selected renal cells (SRC).
Also known as: Rilparencel
a procedure in which a small sample of kidney tissue is removed
Also known as: Kidney Biopsy
Change in Renal Function
Serial measurements of estimated glomerular filtration rate (eGFR) obtained pre-randomization and at three-month intervals through 24 months after the last REACT injection in the active treatment group and at least 12 months post last REACT injection in the deferred treatment group.
Time frame: Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm
Treatment emergent adverse events
Treatment emergent adverse events, serial safety laboratory results
Time frame: Through 24 months following last REACT injection for the active arm and at least 12 months following the last REACT injection for the deferred arm
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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