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Trial intelligence / Profile preview
REACT in Diabetes and Chronic Kidney Disease
NCT05018416Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2021
- Primary completion
- May 2025
- Countries
- 1
- Sponsor
- ProKidney
- Modality
- Adoptive Cell Transfer
- Drugs
- rilparencel
- Conditions
- chronic kidney disease (CKD)
01
Overview
Phase 2, randomised, open-label trial of rilparencel in chronic kidney disease (CKD) (2 cohorts), sponsored by ProKidney. Primary endpoints: Estimated Glomerular Filtration Rate slope at 28 months and Treatment-Emergent Adverse Events. Started Jul 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Cohort 1
Two scheduled REACT injections 3 months apart.
Cohort 2
One scheduled REACT injection with a possible second injection based on a renal function trigger.
03
Who it enrols
Patients aged 30-80 with T1DM or T2DM, diabetic nephropathy, HbA1c < 10%, and eGFR between 20-50 mL/min/1.73m².
04
Endpoints
Primary
Estimated Glomerular Filtration Rate slope
Treatment-Emergent Adverse Events
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