Clinical Trials Directory

Trials / Completed

CompletedNCT03657004

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
145 (actual)
Sponsor
University of Giessen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Timeline

Start date
2018-08-29
Primary completion
2019-08-29
Completion
2019-08-29
First posted
2018-09-04
Last updated
2019-09-26

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03657004. Inclusion in this directory is not an endorsement.