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NCT05601271
Effect of Allopurinol on Markers of Mineral and Bone Metabolism
Conditions: Chronic Kidney Diseases, Osteodystrophy, Uric Acid Concentration, Serum, Quantitative Trait Locus 7
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: University of Sao Paulo General Hospital
Location: Brazil
Summary
Hyperuricemia is a common condition in patients with chronic kidney disease (CKD) in the glomerular filtration rate.
Recently, it has been suggested that uric acid is related to a mineral and bone disease of CKD (CKD-MBD) since the high concentration of uric acid is associated with the harmful effect of vitamin D. The proof of concept of the association between acid uric acid and CKD-MBD is based on a prospective study (sample size 6) that observed, after 1 week of use of allopurinol, an increase in the concentration of 1,25(2D, a result independent of the concentration of calcium, phosphorus, 25(OH)D and PTH.
An experimental study found that hyperuricemia could modify the expression of the 1α-hydroxylase enzyme, consequently reducing 1,25(OH).
The current study aims to evaluate the action of allopurinol on CKD-MBD biomarkers (25(OH)-vitamin D, 1,25(OH)2D, FGF-23, PTH, calcium and phosphorus).
We hypothesize that allopurinol can improve serum levels of 1,25(OH) 2D and PTH.
This is a controlled, randomized, double-blind study, defined as a filtration rate < 60ml/1.73
m², according to the CKD-EPI equation.
Inclusion criteria: patients with stages III, IV and V CKD who are not on dialysis with a serum level of 25(OH)-vitamin D >20 ng/ml.
Exclusion criteria: Patients diagnosed with gout, undergoing treatment with allopurinol, patients already in use and drugs with sensitivity to the drug.
Based on a previous study, we calculated a sample for 2 groups (placebo and drug) with pre and post-measurements (a total of 4).
Considering a standard deviation of 4 and a difference of 7 in the treated group, 3 in the placebo group, and an alpha error of 5%, we calculated a sample of 25 patients in each arm.
Eligibility Criteria
Inclusion Criteria: stage 3, 4 or 5 CKD on conservative management-Exclusion Criteria:allergy to allopurinolcurrent treatment with allopurinolGout
Source: ClinicalTrials.gov (NCT05601271). StuddyBuddy aggregates publicly available trial information.