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Interstitial Lung Abnormalities in Renal Transplant Recipients

NCT ID: NCT01017757

Last Updated: 2009-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Renal Transplantation Kidney-pancreas Transplantation

Keywords

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Interstitial lung disease Immunosuppressive therapy Renal transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Renal transplant patients

High-resolution CT scanning

Intervention Type PROCEDURE

High-resolution CT scanning

Interventions

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High-resolution CT scanning

High-resolution CT scanning

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Parma

OTHER

Sponsor Role lead

Responsible Party

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University of Parma

Principal Investigators

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Carlo Buzio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Parma

Locations

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

Parma, Parma, Italy

Site Status

Countries

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Italy

Other Identifiers

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LungCtRenalTx

Identifier Type: -

Identifier Source: org_study_id