Study Comparing Rifampicin, Isoniazid, and Rifapentine Regimens for Treating Latent Tuberculosis in Patients with End-Stage Kidney Disease

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What is this study about?

This clinical trial is focused on treating latent tuberculosis infection in patients who have end-stage kidney disease. Latent tuberculosis infection means that the bacteria causing tuberculosis are present in the body but are not currently causing symptoms. End-stage kidney disease is a severe form of kidney disease where the kidneys are no longer able to work as they should. The study is testing three different treatment plans to see which one helps patients complete their treatment most effectively. The treatments being tested include three months of daily isoniazid plus rifampicin (known as 3HR), three months of once-weekly isoniazid plus rifapentine (known as 3HP), and four months of daily rifampicin (known as 4R).

The purpose of the study is to find out if the 3HP or 4R treatment plans are better than the 3HR plan for helping patients complete their treatment for latent tuberculosis infection. Participants in the study will be randomly assigned to one of these three treatment plans. The study will monitor how well participants stick to their assigned treatment over a period of time. The treatments involve taking medication by mouth, and the study will track how many doses are completed within a set timeframe.

Throughout the study, researchers will also look at other factors, such as whether participants stop their treatment due to side effects and the overall number of participants who pass away during the study. The study aims to provide valuable information on the best way to treat latent tuberculosis infection in patients with end-stage kidney disease, helping to improve care for these individuals in the future.

1 enrollment

Eligibility is confirmed for patients 18 years or older with end-stage kidney disease who require treatment for latent tuberculosis infection.

A negative pregnancy test is required for female participants before joining the study.

Female participants of childbearing age must agree to use appropriate barrier contraceptive measures.

Informed written consent is obtained.

2 treatment assignment

Participants are randomly assigned to one of three treatment regimens for latent tuberculosis infection.

3 3HR regimen

Participants in this group take isoniazid and rifampicin daily for three months.

A total of 90 doses must be completed within a maximum of 16 weeks.

Interruptions longer than two weeks are not allowed, and interruptions can occur no more than twice.

4 3HP regimen

Participants in this group take isoniazid and rifapentine once weekly for three months.

A total of 12 doses must be completed within a maximum of 14 weeks.

Interruptions longer than 10 days are not allowed.

5 4R regimen

Participants in this group take rifampicin daily for four months.

A total of 120 doses must be completed within a maximum of 20 weeks.

Interruptions longer than two weeks are not allowed, and interruptions can occur no more than twice.

6 monitoring and follow-up

Participants are monitored for treatment completion and any adverse events.

The primary goal is to determine the proportion of participants who complete the assigned treatment regimen.

Secondary goals include monitoring for adverse events and recording any discontinuations due to these events, as well as tracking mortality during the study.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must have kidney disease stage 5, which means their kidneys are not working well (glomerular filtrate rate less than 15 mL/minute) or they are on substitutive renal therapy, which is a treatment that helps do the work of the kidneys.
Patients must need treatment for latent tuberculosis infection, which is when someone has the tuberculosis bacteria in their body but is not sick or contagious.
Female patients must have a negative pregnancy test before joining the study.
Female patients of childbearing age must be willing to use appropriate barrier contraceptive measures, which are methods to prevent pregnancy.
Patients must provide informed written consent, meaning they agree to participate in the study after understanding what it involves.

Who Cannot Join the Study?

Patients who do not have latent tuberculosis infection. This means the person does not have the bacteria that cause tuberculosis in their body without showing symptoms.
Patients who do not have end-stage kidney disease. This is a condition where the kidneys are no longer able to work as they should to meet the body’s needs.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
Hetypgem Vkcx dvwgxxff	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.10.2023

Trial locations

Investigated drugs:

Isoniazid is a medication used to treat and prevent tuberculosis. In this trial, it is combined with other medications to see how well it works in treating latent tuberculosis infection in patients with end-stage kidney disease.

Rifampicin is an antibiotic used to treat various bacterial infections, including tuberculosis. In this study, it is used both in combination with isoniazid and on its own to evaluate its effectiveness in treating latent tuberculosis infection.

Rifapentine is another antibiotic used to treat tuberculosis. In this trial, it is combined with isoniazid to test if this combination is more effective in treating latent tuberculosis infection compared to other regimens.

Investigated diseases:

Latent Tuberculosis Infection – This condition occurs when a person is infected with the bacteria that cause tuberculosis, but the bacteria remain inactive in the body. Individuals with latent tuberculosis do not exhibit symptoms and are not contagious. However, the bacteria can become active, leading to active tuberculosis disease, especially in people with weakened immune systems. In patients with end-stage kidney disease, the risk of progression from latent to active tuberculosis is higher due to their compromised health. The condition requires monitoring to prevent the development of active tuberculosis.

Trial ID:

2023-506432-32-00

Protocol code:

PI21/004444

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Rifampicin, Isoniazid, and Rifapentine Regimens for Treating Latent Tuberculosis in Patients with End-Stage Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?