This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD).
This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of multiple doses of SAL0140 in patients with chronic kidney disease (CKD). 249 participants diagnosed with chronic kidney disease will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy). The study will consist of the following 4 periods: screening period, run-in period, double-blind treatment period and follow-up period. Patients will complete the study in approximately 8 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
249
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China
The baseline change of UACR
Change from baseline in UACR compared to placebo at Week 16
Time frame: at week 16
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