One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Description

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.

Conditions

Latent Tuberculosis, End Stage Renal Disease, Renal Transplant Candidate for Right Kidney, Renal Transplant Candidate for Left Kidney

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Study Overview

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Study Details

Study overview

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.

One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Condition
Latent Tuberculosis
Intervention / Treatment

-

Contacts and Locations

New Brunswick

Pinki J Bhatt, New Brunswick, New Jersey, United States, 08901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rutgers, The State University of New Jersey,

Pinki Bhatt, MD, PRINCIPAL_INVESTIGATOR, Rutgers

Study Record Dates

2029-06-30