Latent tuberculosis infection in patients with end-stage kidney disease.
Conditions
Brief summary
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).
Detailed description
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., 2. Proportion of participants who discontinue permanently the assigned treatment because of adverse events, related to the treatment of the study., 3. Crude mortality: Number of participants who die while on the study.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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., 2. Proportion of participants who discontinue permanently the assigned treatment because of adverse events, related to the treatment of the study., 3. Crude mortality: Number of participants who die while on the study. | — |
Countries
Spain