The study is a Phase III clinical trial to evaluate the superiority of HRS-1780 tablets compared with placebo in delaying renal function decline in participants with chronic kidney disease (CKD) on the basis of standard treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,386
Oral tablets
Oral tablets
National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGTime to the first appearance of the composite endpoint:
* Progression of kidney disease (initiation of maintenance dialysis or receiving kidney transplantation or continuous eGFR \<15 mL/min/1.73m², or death due to kidney disease or a ≥40% decrease in eGFR compared to baseline for at least 4 weeks); or * CV Death.
Time frame: month 60
The annualized total slope of eGFR from baseline to 36 months.
Time frame: month 36
The ratio of UACR to baseline at the 6th month .
Time frame: month 6
The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment.
Time frame: month 60
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