An observational study in CKD, ESRD and Hyperuricemia, sponsored by The Institute of Nephrology of the Academy of Medical Sciences of Ukraine. Status unknown at 1 site in Ukraine. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-22.
Sponsored by The Institute of Nephrology of the Academy of Medical Sciences of Ukraine · Observational
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.
215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.
This study's planned enrollment of 250 is above the median of 200 across 37 observational studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →This is the only study on the registry with The Institute of Nephrology of the Academy of Medical Sciences of Ukraine as lead sponsor.
Counted across the registry records on this site, refreshed daily.
CKD stage 1-5 patients
Exclusion Criteria:
Renal Survival for CKD stages 1-3
Time frame: 3 years
Cardio-vascular Events
Time frame: 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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