Viral load-guided immunosuppression after lung transplantation (VIGILung)—study protocol for a randomized controlled trial
| العنوان: | Viral load-guided immunosuppression after lung transplantation (VIGILung)—study protocol for a randomized controlled trial |
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| المؤلفون: | Carmen Schade-Brittinger, Alexander Reuss, Karin Weide, Konstantin Mayer, Peter Jaksch, Jens Gottlieb, Susanne Hoyer |
| المصدر: | Trials Trials, Vol 22, Iss 1, Pp 1-10 (2021) |
| بيانات النشر: | BioMed Central, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Graft Rejection, medicine.medical_specialty, medicine.medical_treatment, Medicine (miscellaneous), Kidney failure, 030230 surgery, law.invention, 03 medical and health sciences, Study Protocol, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Multicenter trial, Clinical endpoint, Medicine, Lung transplantation, Humans, Multicenter Studies as Topic, Pharmacology (medical), 030304 developmental biology, Randomized Controlled Trials as Topic, Torque teno virus, Immunosuppression Therapy, lcsh:R5-920, 0303 health sciences, medicine.diagnostic_test, business.industry, Immunosuppression, Viral Load, Tacrolimus, Transplantation, Therapeutic drug monitoring, lcsh:Medicine (General), business, Immunosuppressive Agents |
| الوصف: | Background Immunosuppression including high-dose calcineurin inhibitors (CNI) is essential after lung transplantation. Dosing is usually guided by therapeutic drug monitoring adjusted to target trough levels of CNIs to keep the balance between over-dose causing severe toxicity and increased risk of infections or under-dose with a risk of graft injury. Adaptation of CNI-based immunosuppression by monitoring of torque teno virus (TTV), a latent nonpathogenic DNA virus, measured in the whole blood in addition to conventional therapeutic drug monitoring may reduce the toxicity of immunosuppression with similar efficacy. Methods/design An open-label, randomized, controlled, parallel-group, multicenter trial in lung transplant recipients will be conducted to investigate the safety and efficacy of immunosuppression guided by TTV monitoring as an add-on to conventional therapeutic drug monitoring. Adult lung transplant recipients 21 to 42 days after transplantation are eligible to participate. Patients (N = 144) will be randomized 1:1 to the experimental intervention (arm 1: immunosuppression guided by TTV monitoring in addition to conventional therapeutic drug monitoring of tacrolimus trough levels) and control intervention (arm 2: conventional therapeutic drug monitoring). Outcomes will be assessed 12 months after randomization with the change in glomerular filtration rate as the primary endpoint. Secondary endpoints will be additional measurements of renal function, allograft function, incidence of acute rejections, incidence of chronic lung allograft dysfunction, graft loss, and infections. Discussion The results of this randomized controlled trial may reduce the toxicity of immunosuppression after lung transplantation while maintaining the efficacy of immunosuppression. Study results are transferable to all other solid organ transplantations. Trial registration ClinicalTrials.gov NCT04198506. Registered on 12 December 2019 |
| اللغة: | English |
| تدمد: | 1745-6215 0419-8506 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ddb166ad650a276f9b9f72a4f5dedcb7 http://europepmc.org/articles/PMC7798016 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....ddb166ad650a276f9b9f72a4f5dedcb7 |
| قاعدة البيانات: | OpenAIRE |
Find this article in full text from Springer Verlag. | تدمد: | 17456215 04198506 |
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