Ended Therapeutic use (Phase IV) Latent tuberculosis infection in patients with end-stage kidney disease.

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

EU CTIS ID: 2023-506432-32-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. 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.
  • 2. Female with negative pregnancy test prior to enrolment.
  • 3. Female of childbearing age willing to take appropriate barrier contraceptive measures.
  • 4. Informed written consent.

You likely can't join if

  • 1. Prior allergy/intolerance to rifamycins or isoniazid.
  • 2. Pregnancy or breastfeeding.
  • 3. Pre-treatment transaminases (ALT and/or AST) >5-fold of the upper limit of the normality titer.
  • 4. Concomitant treatment with drugs contraindicated with the study medications.
  • 5. Having received rifamycins or isoniazid within the two previous weeks.
  • 6. Weigh <32 Kgs.
See the full eligibility criteria
Who can join
  • 1. 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.
  • 2. Female with negative pregnancy test prior to enrolment.
  • 3. Female of childbearing age willing to take appropriate barrier contraceptive measures.
  • 4. Informed written consent.
What rules you out
  • 1. Prior allergy/intolerance to rifamycins or isoniazid.
  • 2. Pregnancy or breastfeeding.
  • 3. Pre-treatment transaminases (ALT and/or AST) >5-fold of the upper limit of the normality titer.
  • 4. Concomitant treatment with drugs contraindicated with the study medications.
  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.