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

NCT ID: NCT03657004

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-29
• Study Completion Date: 2019-08-29

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.

Conditions

Lung Transplant; Complications; Chronic Kidney Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Giessen

OTHER

Sponsor Role: lead

Responsible Party

Faeq Husain

Senior physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Werner Seeger, MD

Role: STUDY_DIRECTOR

University Hospital Giessen and Marburg, Department of Internal Medicine II

Locations

University Hospital Giessen and Marburg

Giessen, Hesse, Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 21975352 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25701373 (View on PubMed)

Other Identifiers

Giessen

Identifier Type: -

Identifier Source: org_study_id