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Transplantation LungVIGILungNCT04198506

Viral Load Guided Immunosuppression After Lung Transplantation

A study testing Tailored tacrolimus dosing and Conventional tacrolimus dosing in people with Transplantation Lung, run by Philipps University Marburg at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transplantation Lung
What is being tested?
Tailored tacrolimus dosing and Conventional tacrolimus dosing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
2 sitesin 2 countries
Study dates
5 Aug 2020to 10 Mar 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • Medizinische Universität Wien, Klinische Abteilung für Thoraxchirurgie

    Vienna, 1090

Other trials in Austria

Germany1 site

  • Klinik für Pneumologie OE 6870, Medizinische Hochschule Hannover

    Hanover, 30625

Other trials in Germany

About this study

Official title: 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.

Being tested
Tailored tacrolimus dosing, Conventional tacrolimus dosing
Keywords
lung transplantation, dosing immunosuppression, toxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailored tacrolimus dosingOther

    Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring -TDM) and additionally depending on TTV viral load.

  • Conventional tacrolimus dosingOther

    Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM).

Study groups in NCT04198506
Study groupRoleWhat they receive
Tailored tacrolimus dosingExperimentalTacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM) and additionally depending on TTV viral load.
Receives: Other: Tailored tacrolimus dosing
Conventional tacrolimus dosingActive comparatorTacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM).
Receives: Other: Conventional tacrolimus dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ΔGFR change of the glomerular filtration rate GFR

    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.

    Measured: Between randomization and 12 months thereafter

Secondary outcomes (23)

  1. GFR (CKD-EPI)

    Glomerular filtration rate (the Chronic Kidney Disease Epidemiology Collaboration - CKD-EPI) formula

    Measured: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization

  2. GFR (Cystatin)

    Glomerular filtration rate (Cystatin)

    Measured: At randomization and 12 months after randomization

  3. proportion of patients with biopsy-proven acute cellular rejection (grade A1 or higher)

    Proportion of patients with biopsy-proven acute cellular rejection (grade A1 or higher), between randomization and 12 months after randomization

    Measured: Between randomization and 12 months after randomization

  4. proportion of patients with an episode of biopsy-proven lymphocytic bronchitis (grade B1R or higher)

    proportion of patients with an episode of biopsy-proven lymphocytic bronchitis (grade B1R or higher)

    Measured: Between randomization and 12 months after randomization

  5. proportion of patients with cytomegalovirus (CMV)-infection and number of CMV-disease episodes

    proportion of patients with cytomegalovirus (CMV)-infection and number of CMV-disease

    Measured: Between randomization and 12 months after randomization

  6. proportion of patients with community-acquired respiratory viral infection (CARV)

    proportion of patients with community-acquired respiratory viral infection (CARV)

    Measured: Between randomization and 12 months after randomization

  7. proportion of patients with fungal and bacterial infections

    proportion of patients with fungal and bacterial infections

    Measured: Between randomization and 12 months after randomization

  8. proportion of patients with any of the above mentioned infections

    proportion of patients with any of the above mentioned infections

    Measured: Between randomization and 12 months after randomization

  9. proportion of patients with unscheduled or emergency hospitalizations

    proportion of patients with unscheduled or emergency hospitalizations

    Measured: Between randomization and 12 months after randomization

  10. proportion of patients with ICU admissions

    proportion of patients with ICU admissions

    Measured: Between randomization and 12 months after randomization

  11. quality of life (EQ-5D visual analog scale)

    European Quality of Life 5 Dimensions - EQ-5D

    Measured: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization

  12. proportion of patients with new or progressive malignancy

    proportion of patients with new or progressive malignancy

    Measured: Between randomization and 12 months after randomization

  13. tacrolimus trough levels

    tacrolimus trough levels

    Measured: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization

  14. daily tacrolimus dose [mg]

    daily tacrolimus dose [mg]

    Measured: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization

  15. proportion of patients with increased/unchanged/decreased (compared to previous visit) target trough levels of tacrolimus

    proportion of patients with increased/unchanged/decreased (compared to previous visit)

    Measured: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization

  16. exercise capacity measured by the percent predicted distance achieved in the 6-minute walk test (6-MWT)

    exercise capacity measured by the percent predicted distance achieved in the 6-minute walk test (6-MWT)

    Measured: at randomization and 12 months thereafter

  17. CD4-Lymphocytes counts

    CD4-Lymphocytes counts

    Measured: 0, 6 and 12 months after randomization

  18. proportion of patients with presence of donor specific antibodies

    proportion of patients with presence of donor specific antibodies

    Measured: 0, 6 and 12 months after randomization

  19. FEV1 in % baseline value

    FEV1 in % baseline value

    Measured: 1 and 2 months after transplantation (screening visits) and 0, 3, 6, 9 and 12 months after randomization

  20. incidence of chronic lung allograft dysfunction

    incidence of chronic lung allograft dysfunction

    Measured: Between randomization and 12 months thereafter

  21. IgG-level

    IgG-level

    Measured: 0, 6 and 12 months after randomization

  22. proportion of patients with rescue immunotherapy (defined by the use of ATG, Rituximab, Alemtuzumab, plasma exchange, immunoadsorption)

    proportion of patients with rescue immunotherapy (defined by the use of ATG, Rituximab, Alemtuzumab, plasma exchange, immunoadsorption)

    Measured: Between randomization and 12 months thereafter

  23. time from randomization to graft loss (defined as re-do transplantation or death)

    time from randomization to graft loss (defined as re-do transplantation or death)

    Measured: randomization until 12 months thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start5 Aug 2020
  3. Primary completion7 Mar 2025
  4. Study completion10 Mar 2025

Resources

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
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04198506
Sponsor's protocol ID
KKS-256
Other IDs
2019-001770-29, 2019
Acronym
VIGILung
Status last verified
Mar 2025
First submitted
5 Dec 2019
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Gottlieb J, Reuss A, Mayer K, Weide K, Schade-Brittinger C, Hoyer S, Jaksch P. Viral load-guided immunosuppression after lung transplantation (VIGILung)-study protocol for a randomized controlled trial. Trials. 2021 Jan 11;22(1):48. doi: 10.1186/s13063-020-04985-w.

    PubMed 33430927

Questions about this trial

What is this clinical trial studying?

A study testing Tailored tacrolimus dosing and Conventional tacrolimus dosing in people with Transplantation Lung, run by Philipps University Marburg at 2 sites in 2 countries.

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 7 inclusion and 13 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, Germany. 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?

ΔGFR change of the glomerular filtration rate GFR (time frame: Between randomization and 12 months thereafter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04198506, which also lists 1 linked publication.

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 30 Mar 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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