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临床试验/NCT05411744
NCT05411744进行中(未招募)4 期

One-month Latent Tuberculosis Treatment for Renal Transplant Candidates

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
25
试验地点
1
主要终点
Rate of adverse events with 1-m INH/RPT/Vit B6

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

1 month Rifapentine, Isoniazid and Vitamin B6

Other

Participants will receive 28 days of self-administered daily doses of RPT, INH, and pyridoxine (vitamin B6).

There are no multiple arms or multiple interventions. All participants will receive all 3 drugs. There are no comparators.

干预措施: 1 month Rifapentine, Isoniazid and Vitamin B6 (Drug)

结局指标

主要结局

Rate of adverse events with 1-m INH/RPT/Vit B6

时间窗: 28 days

Treatment discontinuation due to adverse reaction of study drug determined by investigator

次要结局

  • Rate of treatment compliance(28 days)
  • Rate of treatment completion(28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pinki Bhatt

Associate Professor

Rutgers, The State University of New Jersey

研究点 (1)

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