AndersonBrecon, Inc.

Comparison of BI-EFS in subjects receiving TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy

1. Primary objective: To determine whether SZC is superior to placebo in slowing CKD progression as an adjunct to ACEi/ARB therapy 2. Secondary objectives: a. To determine whether SZC is superior to placebo in reducing the incidence of the composite endpoint of renal failure as an adjunct to ACEi/ARB therapy b. To determine whether SZC is superior to placebo in reducing the incidence of lisinopril/valsartan dose reduction in subjects receiving lisinopril/valsartan at randomization as an adjunct to ACEi/ARB therapy c. To determine whether SZC is superior to placebo in reducing albuminuria as an adjunct to ACEi/ARB therapy d. To determine whether SZC is superior to placebo in increasing serum bicarbonate levels as an adjunct to ACEi/ARB therapy e. To determine whether SZC is superior to placebo in maintaining normal serum potassium levels as an adjunct to ACEi/ARB therapy 3. Safety Objectives To evaluate the safety and tolerability of SZC as an adjunct to ACEi/ARB therapy compared with placebo

The overall response rate (ORR) of ibrutinib in treatment-naïve patients with CLL/SLL was estimated according to the International Working Group on Chronic Lymphocytic Leukemia (iwCLL) consensus guidelines.