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Completed

NCT Number: NCT04198506

Viral Load Guided Immunosuppression After Lung Transplantation

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.

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Key information

Conditions

Transplantation Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Universität Wien, Klinische Abteilung für Thoraxchirurgie, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored tacrolimus dosing

Other

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

Conventional tacrolimus dosing

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. GFR (Cystatin)

    Time frame: At randomization and 12 months after randomization

    Glomerular filtration rate (Cystatin)

  3. 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

  4. 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)

  5. 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

  6. 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)

  7. 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

  8. 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

  9. 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

  10. proportion of patients with ICU admissions

    Time frame: Between randomization and 12 months after randomization

    proportion of patients with ICU admissions

  11. 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

  12. 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

  13. 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

  14. 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]

  15. 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)

  16. 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)

  17. CD4-Lymphocytes counts

    Time frame: 0, 6 and 12 months after randomization

    CD4-Lymphocytes counts

  18. 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

  19. 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

  20. incidence of chronic lung allograft dysfunction

    Time frame: Between randomization and 12 months thereafter

    incidence of chronic lung allograft dysfunction

  21. IgG-level

    Time frame: 0, 6 and 12 months after randomization

    IgG-level

  22. 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)

  23. 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)

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

Viral Load Guided Immunosuppression After Lung Transplantation, an Open-label, Randomized, Controlled, Parallel-group, Multicenter Trial

Acronym: VIGILung

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2019
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.