Proact: A Study of REACT in Type 2 Diabetes and Chronic Kidney Disease
This study, called Proact, is testing a treatment called rilparencel (also known as REACT) for people with type 2 diabetes and chronic kidney disease. Researchers want to see if rilparencel is safe and effective. You might be able to join if you are between 30 and 80 years old and have both conditions, with a specific blood sugar level (HbA1c of 9.5% or lower) and blood pressure (systolic ≤ 140 mm Hg and diastolic ≤ 90 mm Hg). The study will look at how the treatment affects your kidney function over time, specifically the eGFR slope (a measure of kidney health) and important kidney-related events. The current status of this study is unclear.
- Study design
- This is a randomized, multi-center, blinded study with two groups, planning to enroll 685 participants. Participants will be randomly assigned to either receive the treatment or a sham procedure.
- What's involved
- Participants in the treatment group will have a kidney biopsy, followed by two injections of rilparencel into their kidneys, approximately 12 weeks apart. The sham group will have procedures that mimic the biopsy and injections without actual tissue removal or injection.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed until the global trial end date is declared, with primary endpoints measured at 18 months after the 135th participant's first injection and up to 94 months for clinical events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
At a glance
Conditions
Where it's being run
88 sites across 29 statesStudy leadership
- Study Director · STUDY_DIRECTOR · Prokidney
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Surrogate / Intermediate Efficacy Endpoint -eGFR Slope18 months after the 135th participant receives their first injection / sham.
The difference in annualized eGFR slope between the rilparencel and sham cohorts (approximately 18 months after the 135th participant receives their first injection/sham) using the 2021 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) serum creatinine-based equation.
- Clinical EndpointFrom date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.
The time from first injection to the earliest of: * At least 40% reduction in eGFR, sustained for 30 days, OR * eGFR \<15 mL/min/1.73m² with corresponding two-sided 95% CI, sustained for 30 days and/or chronic dialysis, and/or kidney transplant OR * Renal or cardiovascular death