Comparison of three short rifamycin-based regimens to treat latent tuberculosis in patients with end-stage kidney disease.

INTERVENTION: Product Name: Rimactán 300 mg cápsulas duras,Product Code: PRD800530,Pharmaceutical Form: CAPSULE, HARD,Other descriptive name: ,Strength: Rifampicin 300mg,Product Name: Cemidón 300 B6,Product Code: PRD318182,Pharmaceutical Form: TABLET,Other descriptive name: ,Strength: Isoniazid 300mg, Pyridoxine 50mg,Product Name: RIFAPENTINE,Product Code: SUB10311MIG,Pharmaceutical Form: FILM‐COATED TABLET,Other descriptive name: ,Strength: 150mg,Product Name: Rifaldin 300 mg cápsulas,Product Code: PRD421291,Pharmaceutical Form: CAPSULE, HARD,Other descriptive name: ,Strength: Rifampicin 300mg CONDITION: Latent tuberculosis infection in patients with end‐stage kidney disease. Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective:To determine if treatment completion with three months of once‐weekly isoniazid plus rifapentine (3HP) or four months of daily rifampicin (4R) is better compared with three months of daily isoniazid plus rifampicin (3HR) for treatment of latent tuberculosis infection in patients with endstage kidney disease. Primary end point(s):The primary endpoint will be the proportion of participants who complete the assigned treatment regimen, defined as: 1) 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than on 2 occasions, for the 3HR arm (control),2) 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for the 3HP arm (experimental 1),3) 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than on two occasions, for the 4R arm (experimental 2). Secondary Objective:To determine the safety and tolerability of a 3HR, 3HP, and 4R regimens for the treatment of latent TB infection in patients with end‐stage kidney disease. SECONDARY OUTCOME: Secondary end point(s):1. Proportion of participants who discontinue permanently the assigned treatment because of adverse events, regardless of its relationship to the treatment of the study 2. Proportion of participants. Secondary end point(s):2. Proportion of participants who discontinue permanently the assigned treatment because of adverse events, related to the treatment of the study. Secondary end point(s):3. Crude mortality: Number of participants who die while on the study. INCLUSION CRITERIA: 1. Patients 18 years or older with kidney disease stage 5 (glomerular filtrate rate <15 mL/minute or under substitutive renal therapy) who require treatment for latent tuberculosis infection.,2. Female with negative pregnancy test prior to enrolment.,3. Female of childbearing age willing to take appropriate barrier contraceptive measures.,4. Informed written consent.