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One-month TB pill regimen tested for kidney transplant hopefuls

NCT ID NCT05411744

Disease control Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a 1-month course of three medicines (isoniazid, rifapentine, and vitamin B6) to treat latent tuberculosis in 25 adults with end-stage kidney disease who are candidates for a kidney transplant. The goal is to see if this shorter treatment is safe and easy to complete. Participants take the pills daily for 28 days, and researchers track side effects and how many doses are taken.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 of investigator that will interfere with adherence * On non-modifiable medications with significant drug interactions with Rifapentine or INH * On medications known to cause hepatoxicity and/or neutropenia

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure latent tuberculosis infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage renal disease Latent tuberculosis Renal transplant candidate for left kidney Renal transplant candidate for right kidney

Contacts and locations

Locations

  • Pinki J Bhatt

    New Brunswick, New Jersey, 08901, United States

More trials for these conditions

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