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
- Diseases
- Chronic kidney disease, Tuberculosis
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pinki J Bhatt Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.