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

Completed

• Conditions: Lung Transplant; Complications; Chronic Kidney Diseases

• Registration Number: NCT03657004
• Lead Sponsor: University of Giessen

Brief 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.

Study Timeline

• Study Start: 2018-08-29
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-09-04
• Status Verified: 2019-08
• Primary Completion: 2019-08-29
• Study Completion: 2019-08-29
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	2003-2018	Renal function as measured by estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration formula)

Secondary Outcome Measures

Name	Time	Method
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	2003-2018	Rejection as measured by histological assessment

Trial Locations

Locations (1)

University Hospital Giessen and Marburg; 🇩🇪 Giessen, Hessen, Germany