NCT05099770

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 685 (estimated)
• Sponsor: Prokidney · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.

Detailed description

Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will have scripted sham procedures that mimic the sounds and activities of biopsy, injection procedures, and evaluations as a control for Cohort 2 participants who will have a kidney biopsy followed with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later with a second rilparencel injection into the contralateral kidney. All participants will be followed until the global trial end date is declared.

Conditions

• Type 2 Diabetes Mellitus
• Chronic Kidney Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Renal Autologous Cell Therapy (REACT/ rilparencel)	Participants will have a kidney biopsy followed approximately12 weeks later with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later a rilparencel injection into their contralateral kidney.
PROCEDURE	Sham Comparator	Participants will have sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The 2 injection/ sham procedures will occur approximately 12 weeks apart.

Timeline

• Start date: 2022-01-05
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2021-10-29
• Last updated: 2026-03-23

Locations

95 sites across 7 countries: United States, Australia, Canada, Mexico, Puerto Rico, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study