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

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03046914
• Other study ID #: SNUIMA002
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2017
• Last updated: February 7, 2017
• Start date: February 24, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: February 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Stevens-Johnson Syndrome

Intervention

Genetic:
• HLA-B*5801 test
Check whether a participant has HLA-B*5801 allele or not, before administration of allopurinol

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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