hyperuricemia
Conditions
Interventions
Allopurinol group:Receive allopurinol tablets
Sponsors
The Seventh Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with aplastic anemia and the diagnostic criteria is based on China's "Guidelines for the Diagnosis and Treatment of Aplastic Anemia in Children (2019 Edition)"; 2. Male and female children aged 1-18; 3. Immunosuppressive therapy with Cyclosporine (CsA) or antithymocyte globulin (ATG) combined with Cyclosporine; 4. The treatment regimen of cyclosporine must be carried out according to China's Guidelines for the Diagnosis and Treatment of Aplastic Anemia in Children (2019 Edition); 5. Hyperuricemia occurred during cyclosporine treatment: once the blood uric acid is found to be greater than 7 mg/dL (416.5 µmol/L), diet and lifestyle intervention will be given to the children, and which the blood uric acid is still greater than 7 mg/dL (416.5 µmol/L)2 weeks later, will be diagnosed as hyperuricemia; 6. Obtain written informed consent from family members of children.
Exclusion criteria
Exclusion criteria: 1. Previous history of hyperuricemia or gout; 2. Used uric acid lowering drugs before enrollment; 3. HLA-B*5801 gene positive or allergic to allopurinol. 4. Subjects already in a cyclosporine decrement period or expected to undergo cyclosporine decrement during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in blood uric acid concentration from baseline to 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of serum uric acid concentration decreased to 6.0 mg/ dL;Incidence of urate crystal deposition detected by renal Ultrasound at week 0 ?24and 48;Changes in granulocytes, hemoglobin, platelets, ALT, AST, and total bilirubin from baseline to week 24;Changes in eGFR(mL/min/1.73 m2) calculated based on cystatin C from baseline to weeks 2, 4, 12, 24, 26, 28, 36, 48;Changes in renal function related indicators (including serum creatinine, urea nitrogen, cystatin C, serum beta-2 microglobulin, retinol binding protein, urinary beta-2 microglobulin, urinary a1 microglobulin, and urinary microalbumin/creatinine) from baseline to weeks 2, 4, 12, 24, 26, 28, 36, and 48;Systolic/diastolic blood pressure, fasting blood glucose change, percentage above normal from baseline to 2, 4, 12, 24, 26, 28, 36, 48 weeks;Changes in total cholesterol and triglycerides from baseline to weeks 12, 24, 36, and 48;Adverse events, type and incidence of adverse drug reactions from baseline to week 24;Recurrence of hyperuricemia occurred between weeks 24 and 48;Bone marrow aspiration results performed at week 24;Changes in cyclosporine concentration at week 0, 2, and 4 after allopurinol/placebo supplementation and discontinuation;Changes in serum creatinine-based eGFR(mL/min/1.73 m2) from baseline to weeks 2, 4, 12, 24, 26, 28, 36, and 48; | — |
Countries
China
Contacts
Public ContactChun Chen
The Seventh Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed