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

Seoul National University

Status

Unknown

Conditions

Stevens-Johnson Syndrome

Kidney Failure, Chronic

Treatments

Genetic: HLA-B*5801 test

Study type

Interventional

Funder types

Other

Identifiers

NCT03046914

SNUIMA002

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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)