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Completed

NCT Number: NCT03657004

Immunosuppressive Regimen on Changes in Renal Function and Transplant Rejection Rate in Patients With Lung Transplant

This retrospective single-center analyzes the impact of switch of immunosuppressive regimen on renal function and transplant rejection rate in patients with lung transplant.

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Key information

About this study

Lung transplantation (LTx) is the preferred treatment modality for patients with end-stage lung disease. However, despite significant advances in treatment after LTx, comorbidities and medical complications contribute to a major extend to the high morbidity and mortality rate. Chronic kidney disease is common in patients after lung transplantation, and a large proportion of these patients ultimately progress to end-stage renal disease requiring dialysis. Chronic calcineurin inhibitor nephrotoxicity is one of the major risk factors for the development of chronic kidney disease. Mammalian target of rapamycin (mTOR) inhibitors such as everolimus have been increasingly used in combination with calcineurin inhibitors to reduce nephrotoxicity. However, whether a mTOR inhibitor based immunosuppressive regime leads to lower chronic nephrotoxicity remains unknown. The aim of this study is to evaluate whether the switch of the standard immunosuppressive regime after LTx with mycophenolate/tacrolimus/prednisolon to everolimus/tacrolimus/prednisolon is associated with an improved long-term preservation of renal function without increase in rejection rate.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients who underwent lung transplantation at the University Hospital Giessen and Marburg, Campus Giessen and Kerckhoff Clinic Bad Nauheim

Exclusion criteria

  • Patients who died within 3 months after lung transplantation

Treatment and study plan

Primary outcomes

  1. Long-term loss of renal function in patients with standard immunosuppressive regimen after LTx (mycophenolate/tacrolimus/prednisolon) compared to those who switch to a mammalian target of rapamycin inhibitor based immunosuppressive regime

    Time frame: 2003-2018

    Renal function as measured by estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration formula)

Secondary outcomes

  1. Rates of rejection (acute and chronic) in patients with standard immunosuppressive regimen after LTx (mycophenolate/tacrolimus/prednisolon) compared to those who switch to a mammalian target of rapamycin inhibitor based immunosuppressive regime

    Time frame: 2003-2018

    Rejection as measured by histological assessment

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

Impact of Switch of Immunosuppressive Regime on Changes in Renal Function and Transplant Rejection Rate in Patients With Lung Transplant

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Sep 26, 2019

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.

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