Interstitial Lung Abnormalities in Renal Transplant Recipients

• Conditions: Renal Transplantation; Kidney-pancreas Transplantation
• Interventions: Procedure: High-resolution CT scanning

• Registration Number: NCT01017757
• Lead Sponsor: University of Parma

Brief Summary

Immunosuppressive drugs such as tacrolimus, cyclosporine, mycophenolate mofetil, sirolimus and everolimus may have toxic pulmonary effects, particularly interstitial alterations. The aim of the present study is to explore the presence of subclinical interstitial lung abnormalities in stable renal transplant recipients taking the different immunosuppressive drugs used as maintenance therapy for renal transplantation.

Detailed Description

Prospective, cross-sectional study examining the high-resolution CT scans obtained in 63 stable renal transplant recipients taking immunosuppressive treatment for at least 24 months. The findings in patients taking the newer immunosuppressive drugs (mycophenolic acid, sirolimus and everolimus) are compared with those of the patients treated in the traditional way (cyclosporine, tacrolimus, azathioprine). All patients undergo high-resolution CT scanning.

Eligibility criteria: recipients of kidney or kidney-pancreas transplant, on immunosuppressive therapy for at least 24 months, with stable renal function and absence of any overt lung disease or lung alterations induced by other drugs, systemic diseases or occupational exposure to fibrogenic agents.

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-10
• Status Verified: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-20
• Last Update Submitted: 2009-11-20
• Study First Posted: 2009-11-23
• Last Update Posted: 2009-11-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Renal transplant patients with stable renal function taking immunosuppressive therapy for at least 24 months and providing written informed consent to participate to the study

Exclusion Criteria

• Overt lung disorders, lung toxicity due to other drugs or occupational exposure to lung-toxic agents
• Systemic connective tissue disorders or systemic vasculitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Renal transplant patients	High-resolution CT scanning	-

Primary Outcome Measures

Name	Time	Method
Subclinical lung alterations as assessed by high-resolution CT scanning	CT is performed at study entry and, if abnormalities are found, it is repeated at 3-6 months

Trial Locations

Locations (1)

Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital; 🇮🇹 Parma, Italy