Ongoing, recruitingTherapeutic use (Phase IV)Interventional

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)

This research, called the RIFAKiD-TB Trial, is investigating different treatments for latent tuberculosis infection, often called 'silent TB,' in individuals who have severe kidney disease. Latent TB means the bacteria that cause TB are in the body but aren't making someone sick. However, it can become active TB later. The study is comparing three different short-term medicine plans to see which one people are most likely to complete fully. Completing the full course of medication is crucial for preventing latent TB from turning into active TB. Researchers want to understand if there are particular patterns of medication that are easier for patients to stick to, especially given their kidney condition, without causing too many side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Bellvitge University Hospital, Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Enrolment target

225

Start

28 Nov 2023

Latent tuberculosis infection in patients with end-stage kidney disease.

What is this study about?

This study is looking at how well different treatments work for a condition called 'latent tuberculosis infection' – we often call this silent TB. This means the bacteria that cause tuberculosis (TB) are in someone's body, but they aren't currently causing any illness or symptoms. However, there's a risk that this silent infection could become active TB in the future, which is a much more serious illness.

The study focuses on people who also have very severe kidney disease, known as end-stage kidney disease. This group of patients needs special care, and doctors want to find the safest and most effective way to treat their silent TB. The main goal is to compare three different short-term courses of medicine to see which one patients can most easily finish. Completing the full course of treatment is really important to make sure the silent TB doesn't become active TB.

Researchers are tracking how many people finish their medicines, how many stop because of unwanted side effects, and generally how safe the treatments are. The information from this study will help doctors choose the best treatment plans for people with silent TB and serious kidney problems, making sure they get the care they need.

Key takeaways

The study is about treating 'silent TB' in people with serious kidney disease.
It compares three different short-term medicine plans.
The main goal is to find which treatment people are most likely to finish.
Finishing the full course of medicine is very important to prevent active TB.
Both men and women aged 18 and over can participate.
The findings will help doctors better treat future patients.

Who may be eligible?

This study is looking for adults who are 18 years old or older. There is no upper age limit for taking part.

To be eligible, you must have latent tuberculosis infection, which means you have the TB bacteria in your body but you're not currently sick with active TB. You also need to have end-stage kidney disease, which is a serious kidney condition.

Both men and women can take part in this research study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been told you have latent TB (silent TB)?
Do you have end-stage kidney disease?
Are you able to commit to taking study medication and attending appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given one of three different medication plans for your latent TB. These plans involve taking medicines for either three or four months. You'll need to take some medicines daily and others just once a week, depending on which group you're in. The study will carefully track how many doses you take and if there are any breaks in your treatment. You'll also have regular check-ups with the study team to monitor your health, discuss any side effects, and make sure the treatment is going well. The study will continue to follow your progress over several months to see if you complete the treatment and how you feel overall.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving a supervised treatment for your latent TB, which helps prevent it from developing into active TB. This is especially important given your kidney condition, as the study is looking for treatments that are safe and effective for people like you. However, as with any medication, there's a risk of side effects, which the study team will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is 'latent TB'?

Latent TB means you have the bacteria that cause tuberculosis in your body, but you're not sick or showing symptoms. It's like the bacteria are 'asleep'.

Why is it important to treat latent TB?

Treating latent TB helps prevent it from waking up and becoming 'active TB' later, which is a serious illness that can make you very unwell.

What does 'end-stage kidney disease' mean?

This is a serious kidney condition where your kidneys have largely stopped working and need support like dialysis or a transplant.

Will I know which treatment I'm getting?

This study is 'randomised', meaning you'll be put into one of the three treatment groups by chance. This helps make the study fair.

What happens if I have side effects from the medicine?

The study team will closely monitor you for any side effects. If you experience any, you should tell them immediately so they can provide advice and support.