NCT01017757

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
Last Updated

November 23, 2009

Status Verified

November 1, 2009

Enrollment Period

4 months

First QC Date

November 18, 2009

Last Update Submit

November 20, 2009

Conditions

Renal TransplantationKidney-pancreas Transplantation

Keywords

Interstitial lung diseaseImmunosuppressive therapyRenal transplant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Renal transplant patients

Procedure: High-resolution CT scanning

Interventions

High-resolution CT scanningPROCEDURE

High-resolution CT scanning

Renal transplant patients

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Overt lung disorders, lung toxicity due to other drugs or occupational exposure to lung-toxic agents
  • Systemic connective tissue disorders or systemic vasculitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Parma, Parma, 43100, Italy

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Carlo Buzio, MD

    University of Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 23, 2009

Study Start

June 1, 2007

Primary Completion

October 1, 2007

Study Completion

November 1, 2009

Last Updated

November 23, 2009

Record last verified: 2009-11

Locations

IT(1)