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

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Brief Title

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

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

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.
    



Study Type

Interventional


Primary Outcome

An occurrence of allopurinol-induced severe cutaneous adverse reaction


Condition

Stevens-Johnson Syndrome

Intervention

HLA-B*5801 test

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Genetic

Estimated Enrollment

600

Start Date

February 24, 2016

Completion Date

November 30, 2017

Primary Completion Date

November 30, 2017

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03046914

Organization ID

SNUIMA002


Responsible Party

Principal Investigator

Study Sponsor

Seoul National University Hospital

Collaborators

 Ministry of Food and Drug Safety, Korea

Study Sponsor

, , 


Verification Date

February 2017