ACTIVE_NOT_RECRUITING

One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Quick Facts

Study Start:2022-07-01

Study Completion:2029-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05411744

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.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Pinki Bhatt, MD

PRINCIPAL_INVESTIGATOR

Rutgers

Study Locations (Sites)

Pinki J Bhatt

New Brunswick, New Jersey, 08901

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Pinki Bhatt, MD, PRINCIPAL_INVESTIGATOR, Rutgers

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01

Study Completion Date2029-06-30

Study Record Updates

Study Start Date2022-07-01

Study Completion Date2029-06-30

Terms related to this study

Keywords Provided by Researchers

Latent Tuberculosis
End Stage Renal Disease
Renal Transplant Candidate

Additional Relevant MeSH Terms

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