Kidney Failure, Chronic, Stevens-Johnson Syndrome
Conditions
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.
Interventions
GENETICHLA-B*5801 test
Check whether a participant has HLA-B\*5801 allele or not, before administration of allopurinol
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective cases and historical controls
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[Three out of four asterisked (\*) criteria are required for making the diagnosis.\] |
Countries
South Korea
Outcome results
None listed