About this trial
Background:
Elevated plasma oxalate levels in various conditions, including: primary hyperoxaluria due to increased production in the liver, renal failure due to decreased renal excretion, intestinal diseases with fatty diarrhea due to increased intestinal absorption, and increased intake of substances containing oxalate or sources of oxalate. Primary hyperoxaluria type 1 is a rare hereditary disease in which there is an increase in oxalate production in the liver due to a defect in the AGT enzyme in the oxalate metabolism pathway. The disease causes end-stage renal failure, and until recently, the only treatment was liver and kidney transplantation. The disease is more common in our region, and the Pediatric Nephrology Unit is a center of expertise for this disease. In 2022, a new treatment for hyperoxaluria type 1, which is an alternative to liver transplantation (Lomecirane), was added to the health basket. With the introduction of this treatment in Israel, there was a need to test the level of oxalate in plasma in order to monitor the response to treatment and as part of the preparation for kidney transplantation in cases of type 1 hyperoxaluria with end-stage renal failure. There is no laboratory in Israel that performs plasma oxalate testing. The biochemistry laboratory at the Galilee Medical Center performs oxalate testing in urine using an enzymatic method. Testing for oxalate in plasma using this method requires external validation because the manufacturer intends this test for urine only. There are laboratories around the world that use this method to measure oxalate in plasma.
Vitamin C is a precursor (source) for oxalate in the body. High vitamin C levels in dialysis may lead to increased oxalate, which is associated with worsening kidney damage and damage to other organs, including an increase in the incidence of cardiovascular disease. Dialysis patients are therefore advised to avoid vitamin C supplements. On the other hand, cases of symptomatic vitamin C deficiency in dialysis patients have been described due to their tendency to have an inadequate diet. One case was described in the literature by the Nephrology Department at our institution.
Objectives:
1. To validate the plasma oxalate test by comparing it to an external laboratory that performs the test. 2. To examine the relationship between vitamin C levels and plasma oxalate levels in patients with varying degrees of renal failure.
Importance:
1. Establishment of a laboratory service that does not currently exist in Israel and is clinically important for treatment decisions. 2. Assessing the relationship between vitamin C levels and oxalate levels in renal failure will help in the tailored treatment of these patients and prevent complications of vitamin C deficiency on the one hand or hyperoxaluria secondary to vitamin C excess on the other.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signing the informed consent
Disqualifiers
Not willing to participate
Trial population
Healthy patients Dialysis patients without a background of hyperoxaluria Hyperoxaluria patients receiving drug treatment or after a liver transplant Patients with advanced kidney failure not on dialysis
Trial design
Cohort
Prospective
Treatments tested in this trial
This is an non-interventional study
Other interventionOnly blood samples will be required in this study. It is noninterventional.
Treatment groups
Trial outcomes
Primary outcomes
correlation of plasma oxalate between local and external laboratories
The plasma oxalate results from local and external laboratories will be compared by statistical analysis: Comparison tests for paired samples - to examine the differences between two paired samples using the paired sample T test or the Wilcoxon signed rank test if the distribution of the differences is not normal. A 95% confidence interval will be calculated for the difference between the paired samples. Correlation tests -Pearson's correlation coefficient test or alternatively Spearman's correlation coefficient test Bland-Altman plot and Scatter plot curves will be used to demonstrate the difference between the results. A P value lower than 5% will be considered statistically significant. The investigators aim to to have non significant differences between the results of the laboratories in order to conclude that the results in the local laboratory are valid.
Locations
Sponsors and contacts
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Western Galilee Hospital-Nahariya
Lead sponsor
Charite University, Berlin, Germany
Collaborator
This trial is not recruiting at the moment. You can still explore other options: