Effect of Oxalate and Urate Metabolism on CKD Evolution
NCT ID: NCT04399915
Last Updated: 2020-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2019-01-10
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hyperoxalemia/Hyperuricemia Group
No interventions assigned to this group
Hyperoxalemia/Hyperuricemia-free Group
No interventions assigned to this group
Healthy Subjects
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* previous history or actual diagnosis of peritonitis, anemia, systemic and malignant diseases, acute inflammation processes, immunosuppressive treatment and active hepatitis.
18 Years
85 Years
ALL
Yes
Sponsors
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The Institute of Nephrology of the Academy of Medical Sciences of Ukraine
OTHER
Responsible Party
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Locations
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Natalia Stepanova
Kyiv, , Ukraine
Countries
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Facility Contacts
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Other Identifiers
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0119U000002
Identifier Type: -
Identifier Source: org_study_id
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