Hyperuricemia Clinical Trial
Official title:
Effect of Oxalate and Urate Metabolism on the Evolution of Kidney Disease
The current study primarily aimed to characterize the oxalate and uric acid metabolism in CKD patients and to analyze its association with renal survival prognosis. Secondarily, the study is planned to determine whether hyperoxalemia and hyperuricemia are independent risk factors for cardiovascular events and mortality.
The study protocol is approved by a local Ethics Committee and registered in Domestic
Clinical Trial Registry (Identifier 0119U000002). Writing informed consent is obtained from
all subjects participating in the study.
The study will enroll 300 participants (250 CKD patients at stage 1-5 and 50 healthy
subjects). Routine biochemical parameters including blood and daily dialysate concentration
of urea and creatinine, serum albumin, C-reactive protein (CRP), glucose, electrolytes, and
lipid profile parameters will carry out. Total oxalate-degrading activity in fecal samples,
as well as plasma oxalic acid concentration, daily urinary oxalate excretion and peritoneal
dialysis effluent oxalate concentration (if any) will determine. Uric acid will also measure
in serum, urine and dialysate of peritoneal dialysis patients.
The study will be followed up for 3 years. The primary endpoint is cardiovascular events,
secondary endpoints are dialysis adequacy and all-cause mortality. All the endpoints will be
collected, as well as other outcomes, such as chronic inflammation, dyslipidemia and dialysis
dose, and so on. The outcomes will be analyzed using statistical software.
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