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Befejeződött4. fázis

Comparison of three short rifamycin-based regimens to treat latent tuberculosis in patients with end-stage kidney disease.

Key facts

Where
Barcelona, L'hospitalet De Llobregat, Madrid, Palma, Pontevedra és Sevilla, SpanyolországSee the 7 sites
Phase
4. fázis

Where in Spanyolország

  • Hospital del MarBarcelona, SpanyolországNo longer taking part
  • Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
  • Bellvitge University HospitalL'hospitalet De Llobregat, SpanyolországNo longer taking part
  • Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
  • University Hospital Son EspasesPalma, SpanyolországNo longer taking part
  • Complexo Hospitalario Universitario de PontevedraPontevedra, SpanyolországNo longer taking part
  • University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Bellvitge University Hospital
Trial code
EU 2023-506432-32-00
Record updated
2026. április 22.
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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.

Exclusion: 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; Pre-treatment transaminases (ALT and/or AST) >5-fold of the upper limit of the normality titer; Pregnancy or breastfeeding; Weigh <32 Kgs; Inability to understand the nature of the study or to give written consent.

EU CTIS 2023-506432-32-00