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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
685
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.
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.
Surrogate / Intermediate Efficacy Endpoint -eGFR Slope
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.
Time frame: 18 months after the 135th participant receives their first injection / sham.
Clinical Endpoint
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
Time frame: From 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.
Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
• Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
Time frame: From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.
Secondary Endpoint: Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.
• Time from first injection to eGFR \< 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant.
Time frame: From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.
Secondary Endpoint: All-cause mortality.
The time from first injection to all-cause mortality.
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Nephrology Consultants
Huntsville, Alabama, United States
RECRUITINGUniversity of Arizona
Tucson, Arizona, United States
RECRUITINGAmicis Research Center
Beverly Hills, California, United States
ACTIVE_NOT_RECRUITINGParadise Clinical Research Group LLC
Glendora, California, United States
WITHDRAWNKidney Consultants Medical Group
Granada Hills, California, United States
ACTIVE_NOT_RECRUITINGIMD Clinical Trials
Huntington Park, California, United States
RECRUITINGAdvanced Medical Research, LLC
Lakewood, California, United States
RECRUITINGMedicine and Nephrology Associates
Los Alamitos, California, United States
RECRUITINGAcademic Medical Research Institute
Los Angeles, California, United States
RECRUITINGSouthern California Hospital
Los Angeles, California, United States
RECRUITING...and 85 more locations
Time frame: From date of first injection to all-cause mortality assessed up to 94 months.
Secondary Endpoint: Kidney Disease Quality of Life Changes
• Changes from Baseline in patient-reported outcome from the Burden of Kidney Disease domain at Week 52 from the Kidney Disease Quality of Life (KDQOL) Questionnaire. The survey is used to assess the burden, symptoms/problems, and effects of kidney disease on a patient's quality of life.
Time frame: Week 52
Secondary Endpoint: Quality of Life
Changes from Baseline in patient-reported outcome EuroQol 5-Dimension 5-Level (EQ5D-5L) at Week 52. The descriptive system is divided into 5 levels of perceived problems with level 1 (indicating no problem) and level 5 (indicating extreme problems).
Time frame: Week 52