Overview

This trial is active, not recruiting.

Conditions renal transplantation, kidney-pancreas transplantation
Treatment high-resolution ct scanning
Sponsor University of Parma
Start date June 2007
End date October 2007
Trial size 63 participants
Trial identifier NCT01017757, LungCtRenalTx

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
high-resolution ct scanning
High-resolution CT scanning

Primary Outcomes

Measure
Subclinical lung alterations as assessed by high-resolution CT scanning
time frame: CT is performed at study entry and, if abnormalities are found, it is repeated at 3-6 months

Eligibility Criteria

Male or female participants from 18 years up to 82 years old.

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

Additional Information

Official title Cross-sectional Analysis of Subclinical Interstitial Lung Abnormalities in Stable Renal Transplant Recipients by High-resolution CT Scan
Principal investigator Carlo Buzio, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2009.
Information provided to ClinicalTrials.gov by University of Parma.