Clinical trial NCT04399915: Effect of Oxalate and Urate Metabolism on CKD Evolution
Official title: Effect of Oxalate and Urate Metabolism on the Evolution of Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CKD
ESRD
Hyperuricemia
Oxaluria
Keywords: CKD
hemodialysis
peritoneal dialysis
oxalate
uric acid
metabolism
renal survival
cardio-vascular events
Lead sponsor: The Institute of Nephrology of the Academy of Medical Sciences of Ukraine
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD stage 1-5 patients

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age \>18 years old,
* CKD stage 1-4,
* the patients did not take antibiotics and/or probiotics, lipid- and/or urate-lowering therapy for at least past 3 months or:
* dialysis treatment for at least 3 months,
* a stable clinical condition and adequately functioning arteriovenous fistula or peritoneal access,
* a target level of Kt/V (≥ 1.4 for the HD patients and ≥1.7 for the PD patients).

Exclusion Criteria:

* hospitalization in the preceding 3 months,
* previous history or actual diagnosis of peritonitis, anemia, systemic and malignant diseases, acute inflammation processes, immunosuppressive treatment and active hepatitis.

Primary outcomes:
measure: Renal Survival for CKD stages 1-3
timeFrame: 3 years
Secondary outcomes:
measure: Cardio-vascular Events
timeFrame: 3 years
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Natalia Stepanova
Study officials:
References: