One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Jun 6, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a one-month treatment plan for people who have latent tuberculosis (TB) and are candidates for kidney transplants. The researchers want to learn how safe the treatment is, how well participants stick to the plan, and how the body processes the medications. The treatment includes three components: Isoniazid, Rifapentine, and Vitamin B6.

To participate in this study, individuals must be over 18 years old, weigh more than 30 kg, and have end-stage renal disease, meaning their kidneys are not functioning properly. They should not be on a waitlist for a kidney transplant but should be approved by their doctor. Participants will need to have evidence of latent tuberculosis or be at high risk for it, such as having a positive skin test for TB or a history of close contact with someone who has active TB. Those who qualify will receive the treatment and will be closely monitored for any side effects or issues during the study. It’s important to know that if you have certain health conditions or are taking specific medications, you may not be eligible to participate.

Gender

ALL

Eligibility 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