Interstitial Lung Abnormalities in Renal Transplant Recipients (LCRT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Transplantation; Kidney-pancreas Transplantation
• Intervention / Treatment: Procedure: High-resolution CT scanning

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 Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43100
    • Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Kidney or kidney-pancreas recipients, on immunosuppressive therapy for at least 24 months

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Renal transplant patients	Procedure: High-resolution CT scanning; High-resolution CT scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Parma

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (ACTUAL): October 1, 2007
• Study Completion (ANTICIPATED): November 1, 2009

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 20, 2009
• First Posted (ESTIMATE): November 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 23, 2009
• Last Update Submitted That Met QC Criteria: November 20, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Interstitial lung disease; Immunosuppressive therapy; Renal transplant
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: LungCtRenalTx