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Status unknownNCT01017757LCRTUpdated Nov 23, 2009

Interstitial Lung Abnormalities in Renal Transplant Recipients

An observational study in Renal Transplantation and Kidney-pancreas Transplantation, sponsored by University of Parma. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 82 Years. Per ClinicalTrials.gov, last updated 2009-11-23.

Sponsored by University of Parma · Observational

The sponsor has not verified this record recently (last verified Nov 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
18 Years to 82 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Transplantation
  • Kidney-pancreas Transplantation

Keywords

  • Interstitial lung disease
  • Immunosuppressive therapy
  • Renal transplant
03

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 63 is below the median of 153 across 446 observational studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

University of Parma is the lead sponsor of 76 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 82 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)

Groups and cohorts

  • Renal transplant patients

    Procedure: High-resolution CT scanning

Interventions

  • ProcedureHigh-resolution CT scanning

    High-resolution CT scanning

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital
    Parma, 43100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01017757
Lead sponsor
University of Parma
First posted
Nov 23, 2009
Start date
Jun 2007
Primary completion
Oct 2007
Completion
Nov 2009 (estimated)
Last update
Nov 23, 2009

Study contacts

Carlo Buzio, MD
principal investigator · University of Parma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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