A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation

eGFR at 1 year post kidney transplantation

eGFR will be calculated with CKD-EPI 2021 formula, based on the creatinine value, age, and gender of the participant

Time frame: at 1 year

eGFR at 6 months, 2 years, 3 years, 4 years, and 5 years post kidney transplantation

eGFR will be calculated with CKD-EPI 2021 formula, based on the creatinine value, age, and gender of the participant

Time frame: at 6 months, 2 years, 3 years, 4 years, and 5 years

Change of eGFR from Month 3 over time up to 5 years post kidney transplantation

Time frame: from Month 3 over time up to 5 years

Participant status of eGFR > 60 mL/min/1.73 m2 at 1, 2, 3, and 5 years post kidney transplantation

Time frame: at 1, 2, 3, and 5 years

Participant status of eGFR < 60 mL/min/1.73 m² at Month 12 or with a > 10 mL/min/1.73 m² decrease in eGFR from Month 3 to 12

Time frame: from Month 3 to 12

Proteinuria at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation

defined as protein concentration in the urine

Time frame: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

iBox score at 1 year post kidney transplantation

Time frame: at 1 year

Composite of participant and graft survival at 5 years post kidney transplantation

Time frame: at 5 years

Composite of participant and graft survival over time and at 6 months, 1 year, 2 years, 3 years, and 4 years post kidney transplantation

Time frame: at 6 months, 1 year, 2 years, 3 years, and 4 years

Death-censored graft survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of graft loss)

Time frame: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Participant survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of death)

Time frame: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Incidence of BPAR (yearly and cumulative) up to 5 years post kidney transplantation

Time frame: up to 5 years

Time to first BPAR

Time frame: up to 5 years

Incidence of graft rejection at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation

Time frame: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

Incidence of rejection episodes with clinical resolution up to 5 years post kidney transplantation

Time frame: up to 5 years

Composite efficacy failure rate (BPAR, graft loss, and death) by 6 months post kidney transplantation

Time frame: by 6 months

Incidence of de novo donor-specific antibodies at 1 year post kidney transplantation

Time frame: at 1 year

Incidence of de novo donor-specific antibodies at 5 years post kidney transplantation

Time frame: at 5 years

Participants with AEs, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and PCSAs in laboratory tests, ECG, and vital signs during the study period

Time frame: until 5 years

Participants with medical device AEs, ADEs, medical device SAEs, SADEs, and device deficiencies during the study period

Time frame: until 5 years

Side effects of immunosuppressive therapy evaluated by MTSOSD-59R score at Months 1, 2, 3, 4, 5, 6 and then every 6 months until the end of the study

Time frame: at Months 1, 2, 3, 4, 5, 6 and then every 6 months until the end of the study

Frexalimab plasma concentration over time

Time frame: up to 1 year

Incidence of ADA

Time frame: until 5 years

Incidence of new-onset diabetes post kidney transplantation

Time frame: until 5 years

Incidence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure

Time frame: until 5 years

Incidence of dyslipidemia, lipid-lowering regimen, and measures of dyslipidemia, including serum TG and total, non-HDL, LDL, and HDL cholesterol

Time frame: until 5 years

Titer of ADA

Time frame: until 5 years

Persistence of ADA

Time frame: until 5 years

Prevalence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure

Time frame: until 5 years

Prevalence of dyslipidemia, lipid-lowering regimen, and measures of dyslipidemia, including serum TG and total, non-HDL, LDL, and HDL cholesterol

Time frame: until 5 years

Incidence of chronic allograft nephropathy at 1 year

Time frame: At 1 year

HbA1c levels at 3 months, 1, 2, 3, 4, and 5 years post transplantation in non-diabetic participants at baseline.

Time frame: At 3 months, 1, 2, 3, 4, and 5 years

Proportion of baseline non-diabetic participants using insulin and/other anti-diabetic medication at 3 months, 1, 2, 3, 4, and 5 years post transplantation.

Time frame: at 3 months, 1, 2, 3, 4, and 5 years

Incidence of the composite cardiac and cerebrovascular events (cardiovascular death, myocardial infarction, ischemic stroke, and revascularization [surgical or percutaneous] procedures) at 1, 2, 3, 4, 5-year post transplantation.

Time frame: at 1, 2, 3, 4, 5-year

Framingham cardiovascular risk score at 1 year post transplantation

Time frame: at 1 year