One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Isoniazid; Rifapentine; Vitamin B 6

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