| Trial ID: | L1512 |
| Source ID: | NCT05411744
|
| Associated Drug: |
1 Month Rifapentine, Isoniazid And Vitamin B6
|
| Title: |
One-month Latent Tuberculosis Treatment for Renal Transplant Candidates
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Latent Tuberculosis|End Stage Renal Disease|Renal Transplant Candidate for Right Kidney|Renal Transplant Candidate for Left Kidney
|
| Interventions: |
DRUG: 1 month Rifapentine, Isoniazid and Vitamin B6
|
| Outcome Measures: |
Primary: Rate of adverse events with 1-m INH/RPT/Vit B6, Treatment discontinuation due to adverse reaction of study drug determined by investigator, 28 days | Secondary: Rate of treatment compliance, Percentage of daily dosage taken within the 28 day course, 28 days|Rate of treatment completion, Completion of 28 day course within a 5 week period, 28 days | Other: Rate of reactivation of active tuberculosis, Rate of culture-confirmed tuberculosis disease after completing study regimen, 2 years|Trough drug concentration, Isoniazid and Rifapentine serum drug concentration, 28 days|3-hour post-dose drug concentration, Isoniazid and Rifapentine serum drug concentration, 28 days
|
| Sponsor/Collaborators: |
Sponsor: Rutgers, The State University of New Jersey
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-07-01
|
| Completion Date: |
2029-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-10
|
| Locations: |
Pinki J Bhatt, New Brunswick, New Jersey, 08901, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05411744
|
