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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.
In this randomized double-blind study, patients receive allopurinol or a placebo for 3 months.
Dependent variables: 25(OH)-vitamin D, 1,25(OH)2D, FGF-23, PTH, calcium and phosphorus Population: stage 3, 4 or 5 CKD on conservative management at the Nephrology Service of Hospital das Clinicas HCFMUSP, Sao Paulo, Brazil.
The same physician will follow patients. Adverse effects will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | pills exactly as the drug will be delivered to participants. Instructions will be made to take the pill once a day. |
|
| Allopurinol | Active Comparator | pills exactly as the placebo will be delivered to participants. Instructions will be made to take the pill once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol | Drug | Allopurinol 100 to 300 mg a day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1,25 dihydroxivitamin D | Increase in 1,25 dihydroxivitamin D | 3 months |
| FGF-23 | Reduction of FGF-23 | 3 months |
| Klotho | Increase in alpha Klotho | 3 months |
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Inclusion Criteria: stage 3, 4 or 5 CKD on conservative management
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas HCFMUSP | São Paulo | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D002114 | Calcinosis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |