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

Overview

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

Full Title of Study: “Impact of Switch of Immunosuppressive Regime on Changes in Renal Function and Transplant Rejection Rate in Patients With Lung Transplant”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 29, 2019

Detailed Description

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Giessen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Faeq Husain, Senior physician – University of Giessen
  • Overall Official(s)
    • Werner Seeger, MD, Study Director, University Hospital Giessen and Marburg, Department of Internal Medicine II

Citations Reporting on Results

Hellemons ME, Bakker SJ, Postmus D, Verschuuren EA, Erasmus ME, Navis G, van der Bij W. Incidence of impaired renal function after lung transplantation. J Heart Lung Transplant. 2012 Mar;31(3):238-43. doi: 10.1016/j.healun.2011.08.013. Epub 2011 Oct 5.

Guethoff S, Stroeh K, Grinninger C, Koenig MA, Kleinert EC, Rieger A, Mayr T, von Ziegler F, Reichart B, Hagl C, Schramm R, Kaczmarek I, Meiser BM. De novo sirolimus with low-dose tacrolimus versus full-dose tacrolimus with mycophenolate mofetil after heart transplantation–8-year results. J Heart Lung Transplant. 2015 May;34(5):634-42. doi: 10.1016/j.healun.2014.11.025. Epub 2014 Dec 9.

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