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

Seoul National University Hospital600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

600

Conditions

Stevens-Johnson Syndrome Kidney Failure, Chronic

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 1. an estimated or measured glomerular filtration rate \<60 mL/min/1.73 m2 and/or 2. 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

Outcomes

Primary Outcomes

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 \[Three out of four asterisked (\*) criteria are required for making the diagnosis.\]

Time frame: Before 3 months after initiation of allopurinol