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Interstitial Lung Abnormalities in Renal Transplant Recipients (LCRT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Parma.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT01017757
First received: November 18, 2009
Last updated: November 20, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Renal Transplantation
Kidney-pancreas Transplantation
 Procedure: High-resolution CT scanning

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cross-sectional Analysis of Subclinical Interstitial Lung Abnormalities in Stable Renal Transplant Recipients by High-resolution CT Scan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Parma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: June 2007
Estimated Study Completion Date: November 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Renal transplant patients Procedure: High-resolution CT scanning
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.

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017757

Locations
Italy
Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital
Parma, Italy, 43100
Sponsors and Collaborators
University of Parma
Investigators
Principal Investigator: Carlo Buzio, MD University of Parma
  More Information

No publications provided

Responsible Party: Carlo Buzio, University of Parma
ClinicalTrials.gov Identifier: NCT01017757     History of Changes
Other Study ID Numbers: LungCtRenalTx
Study First Received: November 18, 2009
Last Updated: November 20, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Parma:
Interstitial lung disease
Immunosuppressive therapy
Renal transplant

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 19, 2013