Effect of Allopurinol on Markers of Mineral and Bone Metabolism
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo pills exactly as the drug will be delivered to participants. Instructions will be made to take the pill once a day. |
Drug: Allopurinol
Allopurinol 100 to 300 mg a day for 3 months
|
| Active Comparator: Allopurinol pills exactly as the placebo will be delivered to participants. Instructions will be made to take the pill once a day. |
Drug: Allopurinol
Allopurinol 100 to 300 mg a day for 3 months
|
Outcome Measures
Primary Outcome Measures
- 1,25 dihydroxivitamin D [3 months]
Increase in 1,25 dihydroxivitamin D
- FGF-23 [3 months]
Reduction of FGF-23
- Klotho [3 months]
Increase in alpha Klotho
Eligibility Criteria
Criteria
Inclusion Criteria: stage 3, 4 or 5 CKD on conservative management
-
Exclusion Criteria:
-
allergy to allopurinol
-
current treatment with allopurinol
-
Gout
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital das Clinicas HCFMUSP | São Paulo | SP | Brazil | 05403000 |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Alopurinol-CKD-MBD