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NCT05411744Active, not recruitingPhase 4

One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Source: ClinicalTrials.gov · Last updated 21 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
25 (estimated)
First submitted
6 Jun 2022
Start date
1 Jul 2022
Primary completion date
16 Jan 2026
Lead sponsor
Rutgers, The State University of New Jersey
NCT number
NCT05411744

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 25
  • From 1 Jul 2022 to the primary completion date, 16 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior history of treatment for active TB or LTBI
  • 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

Other illness

  • Known history of or active porphyria
  • History of liver cirrhosis
  • Evidence of active acute hepatitis

Lab values

  • 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

Age

  • Age \<18 years

Other

  • Presence of active TB
  • Known exposure to multidrug-resistant TB
  • Peripheral neuropathy \> grade 2

Who the study is looking for

  • 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.

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pinki J Bhatt
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.