In short
Currently, there is 1 ongoing clinical trial investigating treatment options for latent tuberculosis infection in patients with end-stage kidney disease. This trial is comparing different medication regimens to determine the most effective approach for helping patients complete their treatment.
Clinical trial locations
Study Comparing Rifampicin, Isoniazid, and Rifapentine Regimens for Treating Latent Tuberculosis in Patients with End-Stage Kidney Disease
This clinical trial focuses on finding the best treatment approach for latent tuberculosis infection in people who also have end-stage kidney disease. Latent tuberculosis means the bacteria are present in the body but are not causing symptoms or making the person contagious. However, these bacteria can become active later, especially in people with weakened immune systems or serious health conditions like kidney failure.
Who can participate:
- Adults aged 18 years or older
- Patients with severe kidney disease (stage 5), meaning the kidneys are working at less than 15% capacity or the person is receiving kidney replacement therapy
- Individuals who have been diagnosed with latent tuberculosis infection and need treatment
- Female participants must have a negative pregnancy test before joining and agree to use barrier contraception methods if they can become pregnant
- All participants must provide written informed consent
Who cannot participate:
- People who do not have latent tuberculosis infection
- Those without end-stage kidney disease
- Individuals outside the required age range
- People considered part of a vulnerable population requiring special protection
What the trial involves:
The study compares three different treatment plans to see which one helps patients complete their medication course most effectively. Participants are randomly assigned to one of the following treatment groups:
- 3HR regimen: Taking isoniazid and rifampicin daily for three months (90 doses within 16 weeks maximum)
- 3HP regimen: Taking isoniazid and rifapentine once weekly for three months (12 doses within 14 weeks maximum)
- 4R regimen: Taking rifampicin daily for four months (120 doses within 20 weeks maximum)
All medications are taken by mouth. The study monitors how well participants stick to their treatment plan and tracks any side effects or problems that occur. Researchers will also record if anyone needs to stop treatment due to side effects and monitor overall health outcomes during the study period.
Investigational drugs:
The trial uses three established tuberculosis medications:
- Isoniazid: An antibiotic that works by breaking down the protective wall around tuberculosis bacteria, effectively killing them
- Rifampicin: An antibiotic that stops tuberculosis bacteria from multiplying by blocking their ability to produce essential proteins
- Rifapentine: Similar to rifampicin, this medication prevents the bacteria from replicating and is designed to work effectively with less frequent dosing
Purpose of the trial:
The main goal is to determine whether the shorter weekly treatment (3HP) or the four-month daily rifampicin treatment (4R) is better than the standard three-month daily combination (3HR) for helping patients with kidney failure complete their treatment. Completing the full course of medication is essential to prevent latent tuberculosis from becoming active disease. This research is particularly important for people with end-stage kidney disease, who face higher risks of tuberculosis becoming active due to their weakened immune systems.
Summary
There is currently one clinical trial available for patients with latent tuberculosis infection who also have end-stage kidney disease. This trial is being conducted in Spain and focuses on comparing three different medication regimens to identify which approach leads to the best treatment completion rates. The study addresses an important medical need, as patients with severe kidney disease face unique challenges in completing tuberculosis treatment and have an increased risk of the infection becoming active.
The trial examines both combination therapies (isoniazid with rifampicin or rifapentine) and single-drug therapy (rifampicin alone), testing different dosing schedules from daily to once-weekly administration. This research aims to provide valuable evidence to help healthcare providers choose the most effective and manageable treatment option for this vulnerable patient population.
