Prospective Study of Mycobacterium Tuberculosis Specific Cellular immune Responses in Iatrogenically Immunosuppressed Patients: those undergoing TNF-alpha blockade or Awaiting Renal Trasnplants: A Potential New Method For Accurate Diagnosis of Latent Tuberculosis Infection in Clinical Practice - Diagnosis of Latent TB Infection in Anti-TNF alpha or Dialysis
- Conditions
- Renal failure and iatrogenic immunosuppression associated with solid organ transplantation or TNF alpha blockade in rheumatoid arthritisICD 10 codes included: N18 Z94.0 M05 M06 M07 M45
- Registration Number
- EUCTR2005-005664-88-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 520
Patients in chronic renal failure who are potential transplant recipients
OR
Patients with a rheumatological condition who are potential recipients of Tumour Necrosis Factor alpha blockade
AND
adult (over 18)
AND
able to give written informed consent
AND
with risk factors for tuberculosis:
-[renal arm] from collaborating units in high prevalence areas of the UK
-[anti TNF alpha arm] patients who would be considered for tuberculin skin testing under current anti-TNFalpha treatment guidelines, including past history of exposure or disease, immigrant from high prevalence area, CXR changes suggestive of prior TB, grade 2 heaf test or above
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Children
Current active tuberculosis
Unable to give written informed consent
Hypersensitivity to tuberculin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method