Kidney Transplant RecipientNCT01087190
Isoniazid (INH) Treatment Based on ELISPOT Assay
A study testing Isoniazid treatment in people with Kidney Transplant Recipient, run by Asan Medical Center at 1 site in South Korea.
Trial summary
It has been recommended that all transplant recipients undergo a tuberculin skin test (TST) before transplantation. However, the ability of TST to diagnose latent tuberculosis infection (LTBI) in transplant candidates has been reported to be suboptimal because of high rates of false-negative and false-positive… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Kidney Transplant Recipient
- What is being tested?
- Isoniazid treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 831 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years or more
- Kidney transplant recipients
Who cannot join
- Patients who do not receive isoniazid treatment due to abnormal liver function (i.e. Child-Pugh Score B or C)
- Patients who have clinical risk factors for latent tuberculosis infection
- Close contact with a person with pulmonary TB within the past year
- Abnormal chest radiography and no prior prophylaxis
- A history of untreated or inadequately treated TB
- New infection (i.e. a recent conversion of TST to positive status)
- If kidney transplant donor has these clinical risk factors for latent tuberculosis infection, the transplant recipient from this donor will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Open Labeled Trial of Isoniazid Treatment Based on ELISPOT Assay to Prevent Tuberculosis in a Kidney Transplant Recipient
It has been recommended that all transplant recipients undergo a tuberculin skin test (TST) before transplantation. However, the ability of TST to diagnose latent tuberculosis infection (LTBI) in transplant candidates has been reported to be suboptimal because of high rates of false-negative and false-positive results. The enzyme-linked immunospot assay (ELISPOT) detecting interferon-gamma secreting T-cells for diagnosing tuberculosis infection gave promising results in immunocompromised patients as well as in immunocompetent patients. The investigators will perform a randomized, open-label, prospective trial of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients.
Read the detailed description
Our previous data have shown that ELISPOT assay was more sensitive to detect LTBI in renal transplant recipients than TST (Kim SH, et al. Transplant Infect Dis 2010 Jan 25 [Epub ahead of print]). However, further studies are eagerly awaited to determine the efficacy of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients. All adult patients admitted for renal transplantation between May 2010 and April 2013 at the Asan Medical Center, Seoul, South Korea, will be prospectively enrolled. INH (300 mg/day for 9 months) prophylaxis group and no prophylaxis group (control group) will be randomly assigned to all patients with a baseline positive ELISPOT assay regardless of the results of TST. The investigators will compare cumulative probability of developing active TB after transplantation between INH prophylaxis group and control group as primary outcome. Secondary outcomes will be adverse drug reactions, rejection episodes, graft survival, and mortality.
- Conditions
- Kidney Transplant Recipient
- Being tested
- Isoniazid treatment
- Keywords
- kidney, transplantation, tuberculosis, ELISPOT, isoniazid
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoniazid treatmentDrug
isoniazid 300 mg po qd for 9 months
| Study group | Role | What they receive |
|---|---|---|
| INH treatment group | Experimental | * randomly allocated to INH treatment group in renal transplant recipients with ELISPOT (+)
* INH 300 mg po qd for 9 months Receives: Drug: Isoniazid treatment |
| Control group | No intervention | * randomly allocated to control group in renal transplant recipients with ELISPOT (+) * no treatment |
| Observation group | No intervention | * allocated to observation group in renal transplant recipients with ELISPOT (-) * no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of tuberculosis (the rate of tuberculosis after transplantation)
Confirmed tuberculosis Probable tuberculosis Suspected or possible tuberculosis
Measured: 3 years
Secondary outcomes (3)
All cause deaths
- TB-associated deaths
- non-TB-associated deaths
Measured: 3 years
INH-associated adverse drug reactions
liver function abnormalities
Measured: 3 years
Graft failure
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startJun 2010
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Han Kim, Asan Medical Center
- Investigators
- Sung-Han Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087190
- Sponsor's protocol ID
- 2010-0009
- Status last verified
- Dec 2013
- First submitted
- 11 Mar 2010
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Labeled Trial of Isoniazid Treatment Based on ELISPOT Assay to Prevent Tuberculosis in a Kidney Transplant Recipient
- ClinicalTrials.gov ID
- NCT01087190
- Acronym / sponsor ID
- 2010-0009
- Conditions
- Kidney Transplant Recipient
- Keywords
- kidney, transplantation, tuberculosis, ELISPOT, isoniazid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been recommended that all transplant recipients undergo a tuberculin skin test (TST) before transplantation. However, the ability of TST to diagnose latent tuberculosis infection (LTBI) in transplant candidates has been reported to be suboptimal because of high rates of false-negative and false-positive results. The enzyme-linked immunospot assay (ELISPOT) detecting interferon-gamma secreting T-cells for diagnosing tuberculosis infection gave promising results in immunocompromised patients as well as in immunocompetent patients. The investigators will perform a randomized, open-label, prospective trial of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients.
Detailed description
Our previous data have shown that ELISPOT assay was more sensitive to detect LTBI in renal transplant recipients than TST (Kim SH, et al. Transplant Infect Dis 2010 Jan 25 [Epub ahead of print]). However, further studies are eagerly awaited to determine the efficacy of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients. All adult patients admitted for renal transplantation between May 2010 and April 2013 at the Asan Medical Center, Seoul, South Korea, will be prospectively enrolled. INH (300 mg/day for 9 months) prophylaxis group and no prophylaxis group (control group) will be randomly assigned to all patients with a baseline positive ELISPOT assay regardless of the results of TST. The investigators will compare cumulative probability of developing active TB after transplantation between INH prophylaxis group and control group as primary outcome. Secondary outcomes will be adverse drug reactions, rejection episodes, graft survival, and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INH treatment group | Experimental | Drug: Isoniazid treatment* randomly allocated to INH treatment group in renal transplant recipients with ELISPOT (+) * INH 300 mg po qd for 9 months |
| Control group | No intervention | –* randomly allocated to control group in renal transplant recipients with ELISPOT (+) * no treatment |
| Observation group | No intervention | –* allocated to observation group in renal transplant recipients with ELISPOT (-) * no treatment |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 16 years or more
- Kidney transplant recipients
Key exclusion criteria (7 listed)
- Patients who do not receive isoniazid treatment due to abnormal liver function (i.e. Child-Pugh Score B or C)
- Patients who have clinical risk factors for latent tuberculosis infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoniazid treatmentisoniazid 300 mg po qd for 9 months | Drug | INH treatment group |
Primary outcome
Development of tuberculosis (the rate of tuberculosis after transplantation)
Time frame: 3 years
Confirmed tuberculosis Probable tuberculosis Suspected or possible tuberculosis
3 secondary outcomes
All cause deaths
Time frame: 3 years
INH-associated adverse drug reactions
Time frame: 3 years
Graft failure
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Han Kim, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoniazid treatment in people with Kidney Transplant Recipient, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of tuberculosis (the rate of tuberculosis after transplantation) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.