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About
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Full 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 undergo sham procedures and be followed for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.
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Interventional model
Masking
0 participants in 2 patient groups
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Central trial contact
Barbara Tobichuk; Nikola Mirkovic
Data sourced from clinicaltrials.gov
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