Short-course Rifamycin-based Regimens for Latent Tuberculosis in Patients With End-stage Kidney Disease
Status:
Not yet recruiting
Trial end date:
2025-04-30
Target enrollment:
Participant gender:
Summary
Objective To determine if treatment completion with a 4-month rifampin (4R) or 3-month
rifapentine (P) + isoniazid (H) weekly for 12 weeks (3HP) regimens is better than with a
3-month (3HR) regimen for treatment of latent tuberculosis (TB) infection (LTBI) in patients
with end stage kidney disease.
Methods Design: Multicenter, prospective, parallel-group, open-label, controlled clinical
trial.
Study population: All adult patients with ESKD in who treatment for LTBI is prescribed at 7
hospitals.
Interventions: Patients who accept participation, will be randomly assigned to one of the 3
arms: 3HR (control) (90 doses), 4R (120 doses) or 3HP (12 doses).
Outcome: Proportion of participants who discontinue permanently the assigned treatment.
Follow-up: Periodic assessment for permanent or temporary discontinuation, and adverse events
of the assigned treatment.
Sample size: 225 subjects (75 per arm) will be needed to demonstrate, if exists, a 0.16
decrease in permanent discontinuation rates in the experimental arms (4R and 3HP) with
respect to the control arm (3HR), with α= 0.025, β= 0.20, and 5% expected losses, and
assuming a 0.25 proportion of permanent discontinuation in the control.
Phase:
Phase 4
Details
Lead Sponsor:
Miguel Santín
Collaborators:
Institut d'Investigació Biomèdica de Bellvitge Instituto de Salud Carlos III