Document Detail

Prospective randomised trial of isoniazid prophylaxis in renal transplant recipient.
MedLine Citation:
PMID:  15783119     Owner:  NLM     Status:  MEDLINE    
Renal transplantation (RT) recipients are at a high risk of developing tuberculosis (TB) following transplantation. Effectiveness of isoniazid (INH) in preventing TB is well documented in immunocompetent as well as immunocompromised persons. There is paucity of data on role of INH prophylaxis in RT recipients. Thus, a prospective randomised trial of INH in RT recipients was carried out to determine the efficacy of daily INH monotherapy in the prevention of TB in these patients. Patients of end stage renal disease (ESRD) taken for RT formed the subjects of study. Patients with active TB and active hepatitis at the time of RT were excluded from the study. Patients were randomised to receive INH 300 mg with pyridoxine 20 mg daily from the day of RT. The duration of the treatment was planned for 1 year or till the development of TB, which ever was earlier. Between October 1998 and September 2000, 114 RT were done at our hospital. Of these, 24 (21%) patients had active TB at the time of RT and thus were excluded. Patients included were randomised with 1:2 ratio of treatment and control group. Of the 90 patients thus enrolled, 30 were randomised in treatment group and 60 in control group. Of the included patients five patients had very early graft loss (three in treatment and two in control group) within days and thus excluded from the analysis. Three of the 27 (11.1%) patients in treatment group and 15 (25.8%) in control group developed TB (P = 0.10). The risk ratio of (RR) of INH versus control group of TB was 0.36 (95% CI, 0.10-1.32) but the difference was not statistically significant (P = 0.12). Only one patient developed INH induced hepatitis. In conclusion, with INH prophylaxis, there was a trend towards protection from TB, though it was not statistically significant. Further, all patients tolerated INH and hepatotoxicity was not a major problem in this group of patients.
S K Agarwal; S Gupta; S C Dash; D Bhowmik; S C Tiwari
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  International urology and nephrology     Volume:  36     ISSN:  0301-1623     ISO Abbreviation:  Int Urol Nephrol     Publication Date:  2004  
Date Detail:
Created Date:  2005-03-23     Completed Date:  2005-10-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0262521     Medline TA:  Int Urol Nephrol     Country:  Hungary    
Other Details:
Languages:  eng     Pagination:  425-31     Citation Subset:  IM    
Department of Nephrology, AIIMS, New Delhi 110029, India.
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MeSH Terms
Antitubercular Agents / therapeutic use*
Isoniazid / therapeutic use*
Kidney Failure, Chronic / surgery
Kidney Transplantation / adverse effects*
Prospective Studies
Tuberculosis / etiology*,  prevention & control*
Reg. No./Substance:
0/Antitubercular Agents; 54-85-3/Isoniazid

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