One-month treatment for latent tuberculosis in kidney transplant candidates
One-month Latent Tuberculosis Treatment for Renal Transplant Candidates
This study is testing a shorter one-month treatment for latent tuberculosis in kidney transplant candidates to see if it’s safer and easier for patients than the usual nine-month treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (New Brunswick, New Jersey) |
| Trial ID | NCT05411744 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety, compliance, and pharmacokinetics of a one-month treatment regimen using Isoniazid, Rifapentine, and Vitamin B6 for patients with latent tuberculosis who are candidates for renal transplantation. The study aims to address the challenges associated with the standard nine-month treatment, which can lead to delays in transplantation due to compliance issues and adverse effects. By evaluating a shorter treatment duration, the trial seeks to determine if it can achieve similar efficacy with improved patient adherence and fewer side effects. This is a single-center, open-label, prospective study focused on a specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with end-stage renal disease who are awaiting kidney transplantation and have evidence of latent tuberculosis.
Not a fit: Patients under 18 years old or those without latent tuberculosis or high risk for tuberculosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the time and complications associated with preparing renal transplant candidates who have latent tuberculosis.
How similar studies have performed: Other studies have shown success with similar short-duration treatment approaches for latent tuberculosis, indicating potential for this method in renal transplant candidates.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Brunswick, New Jersey
- Pinki J Bhatt — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Pinki Bhatt, MD — Rutgers
- Study coordinator: Pinki J Bhatt, MD
- Email: pb518@rwjms.rutgers.edu
- Phone: 7329392610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.