Viral Load Guided Immunosuppression After Lung Transplantation (VIGILung)

March 25, 2025 updated by: Philipps University Marburg

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Medizinische Universität Wien, Klinische Abteilung für Thoraxchirurgie
  • Germany
      • Hannover, Germany, 30625
        • Klinik für Pneumologie OE 6870, Medizinische Hochschule Hannover

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patients 21 to 42 days after primary de novo lung transplantation (bilateral including combined)
  2. age ≥ 18 years
  3. tacrolimus based immunosuppression
  4. written informed consent
  5. detectable TTV load at randomization (>2,7 log 10)
  6. negative serum pregnancy test in women of childbearing potential.
  7. 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:

  1. patients after unilateral or re-do lung transplantation
  2. history or high-risk of obstructive airway complications after lung transplantation
  3. respiratory failure (need for oxygen therapy or ventilation at screening after lung transplantation)
  4. inability to undergo transbronchial biopsy
  5. advanced kidney failure (GFR CKD-EPI <30 ml/min/1.73m2 at inclusion and/or current renal replacement therapy at inclusion or randomization
  6. advanced liver cirrhosis (CHILD-Pugh Score C) after lung transplantation
  7. fluctuating tacrolimus drug levels (less than 20% in target range after transplantation)
  8. symptoms of significant mental illness and with inability to cooperate or communicate with the investigator.
  9. unlikeliness to comply with the study requirements
  10. HIV positivity
  11. evidence of unsolved drug or alcohol addiction
  12. breastfeeding women
  13. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Active Comparator: Conventional tacrolimus dosing
Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM).
Other: Conventional tacrolimus dosing
Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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 biopsy-proven acute cellular rejection (grade A1 or higher)
Time Frame: Between randomization and 12 months after randomization
Proportion of patients with biopsy-proven acute cellular rejection (grade A1 or higher), 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
proportion of patients with an episode of biopsy-proven lymphocytic bronchitis (grade B1R or higher)
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
proportion of patients with cytomegalovirus (CMV)-infection and number of CMV-disease
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
proportion of patients with community-acquired respiratory viral infection (CARV)
Between randomization and 12 months after randomization
proportion of patients with fungal and bacterial infections
Time Frame: Between randomization and 12 months after randomization
proportion of patients with fungal and bacterial infections
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
proportion of patients with any of the above mentioned infections
Between randomization and 12 months after randomization
proportion of patients with unscheduled or emergency hospitalizations
Time Frame: Between randomization and 12 months after randomization
proportion of patients with unscheduled or emergency hospitalizations
Between randomization and 12 months after randomization
proportion of patients with ICU admissions
Time Frame: Between randomization and 12 months after randomization
proportion of patients with ICU admissions
Between randomization and 12 months after randomization
proportion of patients with new or progressive malignancy
Time Frame: Between randomization and 12 months after randomization
proportion of patients with new or progressive malignancy
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
tacrolimus trough levels
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
daily tacrolimus dose [mg]
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
proportion of patients with increased/unchanged/decreased (compared to previous visit)
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
exercise capacity measured by the percent predicted distance achieved in the 6-minute walk test (6-MWT)
at randomization and 12 months thereafter
CD4-Lymphocytes counts
Time Frame: 0, 6 and 12 months after randomization
CD4-Lymphocytes counts
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
proportion of patients with presence of donor specific antibodies
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
FEV1 in % baseline value
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
incidence of chronic lung allograft dysfunction
Between randomization and 12 months thereafter
IgG-level
Time Frame: 0, 6 and 12 months after randomization
IgG-level
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
proportion of patients with rescue immunotherapy (defined by the use of ATG, Rituximab, Alemtuzumab, plasma exchange, immunoadsorption)
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
time from randomization to graft loss (defined as re-do transplantation or death)
randomization until 12 months thereafter

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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