One-month Latent Tuberculosis Treatment for Renal Transplant Candidates
United States25 participantsStarted 2022-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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…
What they're measuring
1
Rate of adverse events with 1-m INH/RPT/Vit B6
Timeframe: 28 days
Trial details
NCT IDNCT05411744
SponsorRutgers, The State University of New Jersey