Interstitial Lung Abnormalities in Renal Transplant Recipients

Renal Transplantation Clinical Trial

— LCRT  

Official title:

Cross-sectional Analysis of Subclinical Interstitial Lung Abnormalities in Stable Renal Transplant Recipients by High-resolution CT Scan

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01017757
• Other study ID #: LungCtRenalTx
• Status: Active, not recruiting
• Phase: N/A
• First received: November 18, 2009
• Last updated: November 20, 2009
• Start date: June 2007
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: November 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney-pancreas Transplantation
• Renal Transplantation

Intervention

Procedure:
• High-resolution CT scanning
High-resolution CT scanning

Locations

Country	Name	City	State
Italy	Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No