Overview

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:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Miguel Santín
Collaborators:
Institut d'Investigació Biomèdica de Bellvitge
Instituto de Salud Carlos III
Treatments:
Isoniazid
Rifampin
Rifapentine
Criteria
Inclusion Criteria:

1. Age 18 years or older

2. Stage 5 kidney disease (glomerular filtrate rate <15 mL/minute or under substitutive
renal therapy

3. Informed written consent

Exclusion Criteria:

1. Prior allergy/intolerance to rifamycins or isoniazid

2. Pregnancy or breastfeeding

3. Pre-treatment transaminases (ALT and/or AST) >5-fold of normality titer

4. Concomitant drugs contraindicated with rifamycins

5. Having received rifamycins or isoniazid within the two previous weeks

6. Weigh <32 Kgs

7. Inability to understand the nature of the study or to give written consent