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Comparison of treatment completion rates with three short-course rifamycin-based regimens (three months of daily isoniazid plus rifampicin [3HR], three months of once-weekly isoniazid plus rifapentine [3HP], and four months of daily rifampicin [4R]) for treatment of latent tuberculosis infection in patients with end-stage kidney disease: A randomised controlled clinical trial (RIFAKiD-TB Trial)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506432-32-00
Acronym
PI21/004444
Enrollment
225
Registered
2023-11-28
Start date
2024-04-11
Completion date
Unknown
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Latent tuberculosis infection in patients with end-stage kidney disease.

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

DRUGCemidón 300 B6
DRUGRimactán 300 mg cápsulas duras
DRUGRIFAPENTINE

Sponsors

Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026