The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation (PTTKT)

March 21, 2022 updated by: Tao Lin, West China Hospital

The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation (PTTKT):Protocol for an Open-label, Prospective, Randomized, 3-arm, Controlled Trial

Organ transplant recipients are a high incidence group of tuberculosis infection, and the incidence rate is 7-27 times that of the general population. The prevention of postoperative tuberculosis infection is an important part of kidney transplant recipients postoperative follow-up. Taking reasonable tuberculosis prevention strategies for organ transplant recipients can better prevent the occurrence of postoperative tuberculosis and reduce the unreasonable use of anti-tuberculosis drugs. The previous screening methods for active tuberculosis mainly include sputum smear culture, tissue biopsy, tuberculin skin test, tuberculosis antibody, tuberculosis DNA, and chest imaging. However, there is still a lack of accurate and effective means for screening for latent tuberculosis infection. The tuberculosis interferon-γ release test has recently received more and more attention as a means of screening for potential tuberculosis infection. However, how to apply tuberculosis interferon-γ release test in clinical practice is still controversial. The investigators hope to explore the clinical application prospects and practical value of tuberculosis interferon-γ release test through this research.

According to the conclusion of the retrospective study, the investigators found that the recipients with negative TSPOT result maybe don't need follow the isoniazid treatment to prevent the development of tuberculosis even though participants have clinical risk factor of tuberculosis(include past tuberculosis history, the close contact with active tuberculosis patients, an area with a high incidence of tuberculosis, abnormal chest x ray performance ).

The investigators will divided the recipients with tuberculosis risk factors into three groups randomly. Of course, the invention require written informed consent. The first group with positive tuberculosis interferon gamma release assay (TSPOT) result will follow through with the treatment ,which is a daily dose of isoniazid for six months(300mg daily) after kidney transplant surgery. The second group with negative TSPOT result will not follow through the isoniazid treatment. The third group will follow through with the isoniazid treatment no matter their TSPOT results. The investigators will conduct a prospective clinical trial with the first aim of exploring the effectiveness of TSPOT results in kidney transplant recipients with clinical tuberculosis risk factors, and the second aim of exploring the benefit of the isoniazid treatment follow the TSPOT results rather than clinical risk factors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

303

Phase

  • Not Applicable

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.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. living-donor kidney transplantation;
  2. eGFR level > 45ml/min/1.73m2 at discharge;
  3. 18<Age <65years;
  4. receiving standard triad immunosuppressive regimen

Exclusion Criteria:

  1. alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 or more of upper limit of normal
  2. Combined with HBV/HCV/HIV/TB infection in the donor or recipient;
  3. Malignancy history in the donor and recipient;
  4. organ transplant history in the recipient.
  5. The positive TSPOT result or past TB history in the donor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positive TSPOT results with clinical risk factors group
patients receive isoniazid 300mg once daily for six months after kidney transplant surgery form discharge
Drug: Isoniazid
prevent the development of tuberculosis
Placebo Comparator: Negative TSPOT results with clinical risk factors group
patients receive no additional therapy
Other: without any additional anti-tuberculosis treatment
reduce the number of Participants With Treatment-Related Adverse Events
Experimental: Clinical risk factors group
patients receive isoniazid 300mg once daily for six months after kidney transplant surgery form discharge
Drug: Isoniazid
prevent the development of tuberculosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome is the incidence of tuberculosis in these groups.
Time Frame: 12 months
The primary objective of this study is to evaluate the incidence of tuberculosis between these groups. The incidence of tuberculosis was assessed by WHO TB guidelines 2021.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome is subject incidence of adverse events
Time Frame: 12 months
The primary objective of this study is to evaluate the safety of isoniazide among the kidney transplant recipients
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

February 20, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaH-PTTKT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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