One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

End Stage Renal Disease Clinical Trial

Official title: One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Latent tuberculosis infection (LTBI) or inactive tuberculosis, is a common disease found in patients with end-stage renal disease (ESRD) who are being considered for renal transplant (RT). Approximately 5-15% of patients with LTBI will convert to an active form of TB, especially in patients with a weak immune system. Given the morbidity and mortality associated with active TB disease along with the public health threat, LTBI is routinely treated in pre-transplant candidates. While treatment with isoniazid (INH) for 9 months is the mainstay of therapy, its use poses some clinical challenges due to the prolonged duration of treatment, risk of adverse drug effects, and suboptimal compliance and treatment completion. In addition to these challenges, the consequences of delays in transplant due to the time it takes to complete current treatment options are notable. Most recently, there is a large international, randomized, prospective, phase 3 clinical trial by Swindell et al., that found that 1 month of INH and Rifapentine (1m-INH-RPT) compared to the standard 9-month regimen of INH in HIV patients with LTBI had similar TB incidence in both treatment arms but higher compliance rate and fewer adverse events for patients taking 1m-INH-RPT. Given these findings, if a similar study can be conducted in renal transplant candidate population, it can alleviate the aforementioned challenges being faced in RT candidates. Thus, this is a single-arm, open-label, prospective clinical trial investigating the safety, compliance, pharmacokinetics of 1m-INH-RPT in RT candidates. ;

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Latent Tuberculosis
• Renal Transplant Candidate for Left Kidney
• Renal Transplant Candidate for Right Kidney
• Tuberculosis

• NCT number: NCT05411744
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Contact: Pinki J Bhatt, MD
• Phone: 7329392610
• Email: pb518@rwjms.rutgers.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2022
• Completion date: June 30, 2029