This study focuses on secondary hyperparathyroidism (SHPT), a common and serious complication in patients with end-stage renal disease undergoing hemodialysis. SHPT is characterized by persistently elevated parathyroid hormone (PTH) levels due to impaired calcium, phosphate, and vitamin D metabolism. It contributes to bone disorders, vascular calcification, cardiovascular events, and increased mortality. The study also examines hyperuricemia, which frequently coexists in dialysis patients and ma
Conditions
Interventions
Febuxostat 40 mg/day, adjustable based on serum uric acid levels,Standard care without urate-lowering therapy: diet controlled and life style behavioral change
Sponsors
Buriram Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Receiving maintenance hemodialysis for at least 3 months Diagnosed with secondary hyperparathyroidism with serum intact parathyroid hormone level of 300 pg/mL or more Serum uric acid level of 7.0 mg/dL or more in males or 6.0 mg/dL or more in females Stable use of phosphate binders, vitamin D analogs, or calcimimetics for at least 4 weeks Able to understand the study information and provide written informed consent
Exclusion criteria
Exclusion criteria: History of gout flare within the past 1 month Use of febuxostat, allopurinol, or uricosuric agents within the past 4 weeks History of myocardial infarction, stroke, or hospitalization for heart failure within the past 3 months Liver dysfunction defined as aspartate aminotransferase or alanine aminotransferase more than 2 times the upper limit of normal Known hypersensitivity or allergic reaction to febuxostat or xanthine oxidase inhibitors Pregnant or breastfeeding Presence of any serious medical or psychiatric condition that may interfere with study participation, follow-up, or data interpretation such as terminal illness or uncontrolled psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| iPTH 6 months after end of the intervention pg/mL,Uric acid 6 months after end of the intervention mg/dL | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in calcium, phosphate 6 months after end of the intervention mg/dL,Incidence of major adverse cardiovascular events (MACE): non-fatal MI, non-fatal stroke, heart failure hospitalization, CV death 6 months after end of the intervention none,adverse drug reactions 6 months after end of the intervention none,Hospitalization 6 months after end of the intervention event | — |
Countries
Thailand
Contacts
Public ContactTheerapun Boonsayomphu
Buriram Hospital
Outcome results
None listed