Study to evaluate some genetic basis for azathioprine drug induced leukopenia

Completed

Conditions: Autoinflammatory syndromes,

Registration Number: CTRI/2019/07/020354

Lead Sponsor: IPGMER and SSKM Hospital

Brief Summary: Case control study to assess the association of TPMT and NUDT15 gene polymorphisms with azathioprine induced leukopenia in adult patients (18-60 years) suffering from autoimmune diseases.

Azathioprine is a commonly used immunosuppressant with a low therapeutic index. Leukopenia is the most common adverse effect which necessitates dose reduction or drug withdrawal. Studies have suggested a genetic basis for this adverse effect but reports are inconclusive. Studies suggest it is linked with polymorphism of the gene encoding for thiopurine methyltransferase (TPMT) enzyme which is involved in azathioprine metabolism while other studies have refuted it. Recent reportys also suggest that it may be linked to NUDT15(Nudix hydrolase 15) gene polymorphism. Since there are no published studies in eastern Indian population in this area, this study is planned.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

Cases: Adult patients of either gender with a clinical diagnosis of an autoimmune disorder on azathioprine Subjects on azathioprine who developed leukopenia within one year of treatment initiation that necessitated reduction of dose or drug withdrawal Subjects should be willing to give written informed consent regarding study participation Controls shall fulfill all inclusion and exclusion criteria except the occurrence of incidents of leukopenia.
They will be age,gender and ethnicity matched.

Exclusion Criteria

History of moderate to severe leukopenia in the past History of intake of any drugs that it likely to have effect on haematopoietic stem cells History of leukaemia, lymphoma, myelodysplastic syndorme,.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TPMT gene polymorphisms c238G to C c460G to A and c719A to G	within 1 week of enrollment DNA extraction will be done
and NUDT15 polymorphism c415C to T	within 1 week of enrollment DNA extraction will be done

Secondary Outcome Measures

Name	Time	Method
Correlation of TPMT and NUDT15 gene polymorphisms	at outcome

Trial Locations

Locations (1): IPGMER and SSKM Hospital Kolkata
🇮🇳
Kolkata, WEST BENGAL, India
IPGMER and SSKM Hospital Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Dr Abhijnan Ghosh
Principal investigator
7003466065
dr.abhijnan@hotmail.com