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1-Month TB Therapy for Kidney Transplant Candidates
Study Summary
This trial is testing a new combo treatment for renal transplant candidates - 1 month of Isoniazid, Rifapentine and Vitamin B6. They want to see if it's safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have signs of a recent hepatitis infection.I have been treated for TB in the past.I have a history of or currently have porphyria.You are someone who is waiting for a kidney transplant or have been considered for a transplant by a kidney doctor.I weigh more than 30 kilograms.I have a history of liver cirrhosis.I have active tuberculosis.Your total bilirubin level is more than 2.5 times the upper limit of normal.I am older than 18 years.You have a negative pregnancy test from your blood or urine.I am not on medications that badly interact with Rifapentine or INH.Your liver enzymes (AST and ALT) are more than three times the normal level.My kidneys are in the final stage of failure.I have been exposed to TB that is resistant to multiple drugs.I have been exposed to TB or tested positive without active disease.I am taking medication that can affect my liver or lower my white blood cells.Your platelet count is less than 50,000 per microliter of blood.My nerve damage does not severely affect my daily activities.I am under 18 years old.Your body has too few infection-fighting white blood cells.Your hemoglobin level is less than 7.4 grams per deciliter.
- Group 1: 1 month Rifapentine, Isoniazid and Vitamin B6
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are applicants over 70 excluded from participating in the program?
"Aged between 18 and 90, individuals meeting the criteria are eligible to apply for this study. Notably, there is a total of 101 trials available for under-18s while 679 studies have been developed specifically for those aged 65 and above."
Is enrollment open at this time for the experiment?
"According to the data hosted on clinicaltrials.gov, this study is not presently accepting participants. The trial was uploaded initially on July 1st 2022 and has been amended most recently on June 6th 2022. While this specific experiment does not need volunteers currently, there are 756 other studies actively recruiting patients at present."
Has the Food and Drug Administration approved Rifapentine as a treatment?
"Our team concluded that the safety profile of Rifapentine is substantial, giving it a rating of 3 on our scale since this drug has been approved in Phase 4."
Could I join the experiment as a participant?
"This trial has room for 25 participants aged between 18 and 90 that have latent tuberculosis. Additionally, these individuals must fulfill the following criteria: weigh over 30 kgs; present a negative urine or serum pregnancy test; demonstrate evidence of latent TB through either an approved tuberculin skin test ≥ 5 mm, positive quantiferon gold/T-spot with no active pulmonary TB noted on chest radiograph or CT scan OR non-negative TST but high risk for TB as evidenced by prior radiological findings of stable fibronodular changes (including scarring & nodular opacities in apical upper lung zones) & lack of adequate"
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