HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study to Prove the Usefulness of HLA-B*5801 Screening Test for the Prevention of Allopurinol-induced Severe Cutaneous Adverse Reaction in Patient With Chronic Kidney Disease

Conditions
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Stevens-Johnson Syndrome, Kidney Failure, Chronic

Intervention / Treatment
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* Genetic: HLA-B*5801 test


Participation Criteria
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Eligibility Criteria
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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 an estimated or measured glomerular filtration rate <60 mL/min/1.73 m2 and/or evidence of kidney damage (albuminuria, proteinuria, haematuria after exclusion of urological causes, or structural abnormalities on kidney imaging tests) Exclusion Criteria: a subject who refuses to participate in this study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cases and historical controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLA-B*5801 screen test<br>An arm in which a participant takes HLA-B*5801 test before administration of allopurinol | Genetic: HLA-B*5801 test<br>* Check whether a participant has HLA-B*5801 allele or not, before administration of allopurinol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An occurrence of allopurinol-induced severe cutaneous adverse reaction | # Clinical presentations Stevens-Johnson syndrome (SJS), SJS/Toxic epidermal necrolysis (TEN) overlap and TEN were diagnosed according to the range of detached surface area (< 10 %, 10-30 %, and > 30 %, respectively). Drug rash with eosinophilia and systemic symptoms (DRESS) was diagnosed with the following criteria; Hospitalization, Reaction suspected to be drug-related Acute rash, Fever >38°C*, Enlarged lymph nodes at a minimum of 2 sites*, Involvement of at least 1 internal organ*, Blood count abnormalities*, Lymphocytes above or below normal limits, Eosinophils above the laboratory limits, Platelets below the laboratory limits [Three out of four asterisked (*) criteria are required for making the diagnosis.] | Before 3 months after initiation of allopurinol |