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| Name | Class |
|---|---|
| Ministry of Food and Drug Safety, Korea | OTHER_GOV |
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Allopurinol-induced severe cutaneous adverse reaction (SCAR) is a rare but fatal condition. Previous reports have reported that HLA-B*5801 is an important genetic risk factor significantly associated with the development of allopurinol-induced SCAR. However, there has been no prospective study to prove the clinical efficacy of a HLA-B*5801 screening before administration of allopurinol in predicting allopurinol-induced SCAR. The purpose of this prospective study is to test our hypothesis that a pre-screening of HLA-B*5801 will significantly reduce the risk of allopurinol-induced SCAR development compared to the historical control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLA-B*5801 screen test | Experimental | An arm in which a participant takes HLA-B*5801 test before administration of allopurinol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLA-B*5801 test | Genetic | Check whether a participant has HLA-B*5801 allele or not, before administration of allopurinol |
|
| Measure | Description | Time Frame |
|---|---|---|
| An occurrence of allopurinol-induced severe cutaneous adverse reaction | # Clinical presentations
| Before 3 months after initiation of allopurinol |
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Inclusion Criteria:
a subject who needs an allopurinol treatment based on the physician's assessement
a subject with chronic kidney disease (CKD)
CKD is diagnosed on at least 2 occasions for a period of at least 3 months, irrespective of the underlying cause and on the basis
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
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Prospective cases and historical controls
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| D003872 |
| Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |