- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04198506
Viral Load Guided Immunosuppression After Lung Transplantation (VIGILung)
November 17, 2023 updated by: Philipps University Marburg Medical Center
Viral Load Guided Immunosuppression After Lung Transplantation, an Open-label, Randomized, Controlled, Parallel-group, Multicenter Trial
The VIGILung study is an open-label, randomized, multicenter trial in lung transplant recipients to investigate the safety and efficacy of personalized immunosuppression guided by DNA monitoring of Torque-Teno-Virus (TTV).
The aim of the study is to investigate an individual adaptation of the calcineurin inhibitor tacrolimus (tailored calcineurin inhibitor dosing) by a non-invasive biomarker (TTV viral load in whole blood) compared to conventional calcineurin inhibitor dosing.
Indicator for toxicity will be the glomerular filtration rate (GFR), which will be estimated using the CKD-EPI formula.
250 patients (age ≥ 18 years) with 21 to 42 days after de novo lung transplantation (bilateral or combined) will be screened as possible subjects eligible for the study.
N = 144 patients have to be randomized in two study arms.
In Arm 1 tacrolimus doses will be adapted according to the tacrolimus blood level (conventional therapeutic drug monitoring - TDM) and additionally depending on TTV viral load.
In Arm 2 tacrolimus doses will be adapted according to TDM.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jens Gottlieb, Prof. MD
- Phone Number: +49 (0) 511-532-4601
- Email: gottlieb.jens@mh-hannover.de
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients 21 to 42 days after primary de novo lung transplantation (bilateral including combined)
- age ≥ 18 years
- tacrolimus based immunosuppression
- written informed consent
- detectable TTV load at randomization (>2,7 log 10)
- negative serum pregnancy test in women of childbearing potential.
- women of childbearing capacity must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced, a combination of hormonal contraceptive (oral, injectable or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used.
Exclusion Criteria:
- patients after unilateral or re-do lung transplantation
- history or high-risk of obstructive airway complications after lung transplantation
- respiratory failure (need for oxygen therapy or ventilation at screening after lung transplantation)
- inability to undergo transbronchial biopsy
- advanced kidney failure (GFR CKD-EPI <30 ml/min/1.73m2 at inclusion and/or current renal replacement therapy at inclusion or randomization
- advanced liver cirrhosis (CHILD-Pugh Score C) after lung transplantation
- fluctuating tacrolimus drug levels (less than 20% in target range after transplantation)
- symptoms of significant mental illness and with inability to cooperate or communicate with the investigator.
- unlikeliness to comply with the study requirements
- HIV positivity
- evidence of unsolved drug or alcohol addiction
- breastfeeding women
- simultaneous participation in other clinical trials if not permitted by the steering committee
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored tacrolimus dosing
Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM) and additionally depending on TTV viral load.
|
Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring -TDM) and additionally depending on TTV viral load.
|
Active Comparator: Conventional tacrolimus dosing
Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM).
|
Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ΔGFR change of the glomerular filtration rate GFR
Time Frame: Between randomization and 12 months thereafter
|
The primary efficacy endpoint ΔGFR is defined as the change of the glomerular filtration rate GFR between randomization and 12 months thereafter.
GFR will be estimated using the CKD-EPI formula.
|
Between randomization and 12 months thereafter
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GFR (CKD-EPI)
Time Frame: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
Glomerular filtration rate (the Chronic Kidney Disease Epidemiology Collaboration - CKD-EPI) formula
|
1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
GFR (Cystatin)
Time Frame: At randomization and 12 months after randomization
|
Glomerular filtration rate (Cystatin)
|
At randomization and 12 months after randomization
|
proportion of patients with biopsy-proven acute cellular rejection (grade A1 or higher)
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
proportion of patients with an episode of biopsy-proven lymphocytic bronchitis (grade B1R or higher)
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
proportion of patients with cytomegalovirus (CMV)-infection and number of CMV-disease episodes
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
proportion of patients with community-acquired respiratory viral infection (CARV)
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
proportion of patients with fungal and bacterial infections
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
proportion of patients with any of the above mentioned infections
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
proportion of patients with unscheduled or emergency hospitalizations
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
proportion of patients with ICU admissions
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
quality of life (EQ-5D visual analog scale)
Time Frame: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
European Quality of Life 5 Dimensions - EQ-5D
|
1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
proportion of patients with new or progressive malignancy
Time Frame: Between randomization and 12 months after randomization
|
Between randomization and 12 months after randomization
|
|
tacrolimus trough levels
Time Frame: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
|
daily tacrolimus dose [mg]
Time Frame: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
|
proportion of patients with increased/unchanged/decreased (compared to previous visit) target trough levels of tacrolimus
Time Frame: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
|
exercise capacity measured by the percent predicted distance achieved in the 6-minute walk test (6-MWT)
Time Frame: at randomization and 12 months thereafter
|
at randomization and 12 months thereafter
|
|
CD4-Lymphocytes counts
Time Frame: 0, 6 and 12 months after randomization
|
0, 6 and 12 months after randomization
|
|
proportion of patients with presence of donor specific antibodies
Time Frame: 0, 6 and 12 months after randomization
|
0, 6 and 12 months after randomization
|
|
FEV1 in % baseline value
Time Frame: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization
|
|
incidence of chronic lung allograft dysfunction
Time Frame: Between randomization and 12 months thereafter
|
Between randomization and 12 months thereafter
|
|
IgG-level
Time Frame: 0, 6 and 12 months after randomization
|
0, 6 and 12 months after randomization
|
|
proportion of patients with rescue immunotherapy (defined by the use of ATG, Rituximab, Alemtuzumab, plasma exchange, immunoadsorption)
Time Frame: Between randomization and 12 months thereafter
|
Between randomization and 12 months thereafter
|
|
time from randomization to graft loss (defined as re-do transplantation or death)
Time Frame: randomization until 12 months thereafter
|
randomization until 12 months thereafter
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jens Gottlieb, Prof. MD, Klinik für Pneumologie OE 6870, Medizinische Hochschule Hannover (MHH)
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.
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 (Actual)
August 5, 2020
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 5, 2019
First Submitted That Met QC Criteria
December 12, 2019
First Posted (Actual)
December 13, 2019
Study Record Updates
Last Update Posted (Estimated)
November 20, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KKS-256
- 2019-001770-29 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All proposals of scientific question dealing with the data of the VIGLung-trial have to be approved and released by the steering committee of the trial.
IPD Sharing Time Frame
data will be available Begin: one year after publication of results.
End: maximum ten years after publication of results
IPD Sharing Access Criteria
Approval and release by the steering committee
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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