2023-506432-32-00CompletedPhase 4
Comparison of three short rifamycin-based regimens to treat latent tuberculosis in patients with end-stage kidney disease.
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 225 (actual)
- First submitted
- 5 Sept 2023
- Start date
- 11 Apr 2024
- Lead sponsor
- Bellvitge University Hospital
- Diseases
- Tuberculosis
- EU CT number
- 2023-506432-32-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 225
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allergy/intolerance to rifamycins or isoniazid.
- Concomitant treatment with drugs contraindicated with the study medications.
- Having received rifamycins or isoniazid within the two previous weeks.
Lab values
- Pre-treatment transaminases (ALT and/or AST) >5-fold of the upper limit of the normality titer.
Other
- Pregnancy or breastfeeding.
- Weigh <32 Kgs.
- Inability to understand the nature of the study or to give written consent.
Who the study is looking for
- Patients 18 years or older with kidney disease stage ≥ 4 (glomerular filtrate rate ≤29 mL/minute or under substitutive renal therapy) who require treatment for latent tuberculosis infection.
- Female with negative pregnancy test prior to enrolment.
- Female of childbearing age willing to take appropriate barrier contraceptive measures.
- Informed written consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Hospital del Mar | Barcelona | Spain | Completed |
| Bellvitge University Hospital | L'hospitalet De Llobregat | Spain | Completed |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Completed |
| University Hospital Son Espases | Palma | Spain | Completed |
| Complexo Hospitalario Universitario de Pontevedra | Pontevedra | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.