One-month Latent Tuberculosis Treatment for Renal Transplant Candidates
United States25 participantsStarted 2022-07-01
Plain-language summary
This is a prospective, single-center, single-arm, open-label study investigating the safety, compliance and pharmacokinetics of 1-month treatment of Isoniazid, Rifapentine and Vitamin B6 in renal transplant candidates.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and Women Age \> 18
* Weight \> 30 kg
* End-stage renal disease
* Living-related or deceased kidney transplant candidate (not on the waitlist) deemed by their transplant nephrologist
* Negative serum OR urine pregnancy test
* Evidence of latent tuberculosis or high risk for tuberculosis: (1) Confirmed positive tuberculin skin test (TST) ≥ 5 mm or positive quantiferon gold test/T-spot and a chest radiograph or chest CT scan without evidence of active pulmonary TB OR (2) Patients with negative TST or quantiferon gold/T-spot test but high risk for tuberculosis are eligible if they have (i) radiographic evidence of previous TB (stable fibronodular changes, including scarring \[peribronchial fibrosis, bronchiectasis, and architectural distortion\] and nodular opacities in the apical and upper lung zones) and no history of adequate treatment, or (ii) have had close and prolonged contact with a case of active TB.
Exclusion Criteria:
* Age \<18 years
* Absolute neutrophil count of \<750 cells/mm3
* Hemoglobin \< 7.4 g/dL
* Platelets \< 50 x 10E3/uL
* AST (SGOT) and ALT (SGPT) \> 3 times the upper limit of normal (ULN)
* Total bilirubin \> 2.5 times the ULN
* Presence of active TB
* Prior history of treatment for active TB or LTBI
* Known exposure to multidrug-resistant TB
* Known history of or active porphyria
* History of liver cirrhosis
* Evidence of active acute hepatitis
* Peripheral neuropathy \> grade 2
* Active drug or alcohol dependence in opinion…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of adverse events with 1-m INH/RPT/Vit B6
Timeframe: 28 days
Trial details
NCT IDNCT05411744
SponsorRutgers, The State University of New Jersey