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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657004
• Other study ID #: Giessen
• Status: Completed
• Start date: August 29, 2018
• Est. completion date: August 29, 2019

Study information

• Verified date: August 2019
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Lung Transplant; Complications
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Germany	University Hospital Giessen and Marburg	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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 hea — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Renal function as measured by estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration formula)	2003-2018
Secondary	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	Rejection as measured by histological assessment	2003-2018