One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Description

This is a prospective, single-center, single-arm, open-label study investigating the safety, compliance and pharmacokinetics of 1-month treatment of Isoniazid, Rifapentine and Vitamin B6 in renal transplant candidates.Latent tuberculosis infection (LTBI) or inactive tuberculosis, is a common disease found in patients with end-stage renal disease (ESRD) who are being considered for renal transplant (RT). Approximately 5-15% of patients with LTBI will convert to an active form of TB, especially in patients with a weak immune system. Given the morbidity and mortality associated with active TB disease along with the public health threat, LTBI is routinely treated in pre-transplant candidates. While treatment with isoniazid (INH) for 9 months is the mainstay of therapy, its use poses some clinical challenges due to the prolonged duration of treatment, risk of adverse drug effects, and suboptimal compliance and treatment completion. In addition to these challenges, the consequences of delays

Trial Eligibility

Inclusion Criteria: * Men and Women Age \> 18 * Weight \> 30 kg * End-stage renal disease * Living-related or deceased kidney transplant candidate (not on the waitlist) deemed by their transplant nephrologist * Negative serum OR urine pregnancy test * Evidence of latent tuberculosis or high risk for tuberculosis: (1) Confirmed positive tuberculin skin test (TST) ≥ 5 mm or positive quantiferon gold test/T-spot and a chest radiograph or chest CT scan without evidence of active pulmonary TB OR (2) Patients with negative TST or quantiferon gold/T-spot test but high risk for tuberculosis are eligible if they have (i) radiographic evidence of previous TB (stable fibronodular changes, including scarring \[peribronchial fibrosis, bronchiectasis, and architectural distortion\] and nodular opacities in the apical and upper lung zones) and no history of adequate treatment, or (ii) have had close and prolonged contact with a case of active TB. Exclusion Criteria: * Age \<18 years * Absolute neutrophil count of \<750 cells/mm3 * Hemoglobin \< 7.4 g/dL * Platelets \< 50 x 10E3/uL * AST (SGOT) and ALT (SGPT) \> 3 times the upper limit of normal (ULN) * Total bilirubin \> 2.5 times the ULN * Presence of active TB * Prior history of treatment for active TB or LTBI * Known exposure to multidrug-resistant TB * Known history of or active porphyria * History of liver cirrhosis * Evidence of active acute hepatitis * Peripheral neuropathy \> grade 2 * Active drug or alcohol dependence in opinion of investigator that will interfere with adherence * On non-modifiable medications with significant drug interactions with Rifapentine or INH * On medications known to cause hepatoxicity and/or neutropenia

Study Info

Interventions

Locations Recruiting

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