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

Not Applicable

• Conditions: Kidney Failure, Chronic; Stevens-Johnson Syndrome
• Interventions: Genetic: HLA-B*5801 test

• Registration Number: NCT03046914
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-24
• Status Verified: 2017-02
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Study First Posted: 2017-02-08
• Last Update Posted: 2017-02-08
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLA-B*5801 screen test	HLA-B*5801 test	An arm in which a participant takes HLA-B\*5801 test before administration of allopurinol

Primary Outcome Measures

Name	Time	Method
An occurrence of allopurinol-induced severe cutaneous adverse reaction	Before 3 months after initiation of allopurinol	# 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 \[Three out of four asterisked (\*) criteria are required for making the diagnosis.\]

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of