Effect of Oxalate and Urate Metabolism on CKD Evolution

Hyperuricemia Clinical Trial

Official title:

Effect of Oxalate and Urate Metabolism on the Evolution of Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399915
• Other study ID #: 0119U000002
• Status: Recruiting
• Start date: January 10, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2020
• Source: The Institute of Nephrology of the Academy of Medical Sciences of Ukraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• CKD
• ESRD
• Hyperuricemia
• Oxaluria

Locations

Country	Name	City	State
Ukraine	Natalia Stepanova	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
The Institute of Nephrology of the Academy of Medical Sciences of Ukraine

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Survival for CKD stages 1-3		3 years
Secondary	Cardio-vascular Events		3 years