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

February 7, 2017 updated by: Heung-Woo Park, Seoul National University Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HLA-B*5801 screen test
An arm in which a participant takes HLA-B*5801 test before administration of allopurinol
Genetic: HLA-B*5801 test
Check whether a participant has HLA-B*5801 allele or not, before administration of allopurinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
An occurrence of allopurinol-induced severe cutaneous adverse reaction
Time Frame: 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.]
Before 3 months after initiation of allopurinol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2016

Primary Completion (Anticipated)

November 30, 2017

Study Completion (Anticipated)

November 30, 2017

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUIMA002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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