Renal TransplantationLCRTNCT01017757
Interstitial Lung Abnormalities in Renal Transplant Recipients
An observational study of Renal Transplantation and Kidney-pancreas Transplantation, run by University of Parma at 1 site in Italy.
Trial summary
Immunosuppressive drugs such as tacrolimus, cyclosporine, mycophenolate mofetil, sirolimus and everolimus may have toxic pulmonary effects, particularly interstitial alterations. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Renal Transplantation, Kidney-pancreas Transplantation
- What is being tested?
- High-resolution CT scanning
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2007to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney or kidney-pancreas recipients, on immunosuppressive therapy for at least 24 months
Who may be able to join
- 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
Who cannot join
- Overt lung disorders, lung toxicity due to other drugs or occupational exposure to lung-toxic agents
- Systemic connective tissue disorders or systemic vasculitis
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital
Parma, Parma, 43100
About this study
Official title: 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.
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.
- Being tested
- High-resolution CT scanning
- Keywords
- Interstitial lung disease, Immunosuppressive therapy, Renal transplant
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution CT scanningProcedure or surgery
High-resolution CT scanning
| Study group | Role | What they receive |
|---|---|---|
| Renal transplant patients | Not described Receives: Procedure: High-resolution CT scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subclinical lung alterations as assessed by high-resolution CT scanning
Measured: CT is performed at study entry and, if abnormalities are found, it is repeated at 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startJun 2007
- Primary completionOct 2007
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Investigators
- Carlo Buzio, MD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017757
- Sponsor's protocol ID
- LungCtRenalTx
- Acronym
- LCRT
- Status last verified
- Nov 2009
- First submitted
- 18 Nov 2009
- Last updated
- 23 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Analysis of Subclinical Interstitial Lung Abnormalities in Stable Renal Transplant Recipients by High-resolution CT Scan
- ClinicalTrials.gov ID
- NCT01017757
- Acronym / sponsor ID
- LCRT / LungCtRenalTx
- Keywords
- Interstitial lung disease, Immunosuppressive therapy, Renal transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2009 (estimated)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal transplant patients | – | Procedure: High-resolution CT scanning |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney or kidney-pancreas recipients, on immunosuppressive therapy for at least 24 months
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Overt lung disorders, lung toxicity due to other drugs or occupational exposure to lung-toxic agents
- Systemic connective tissue disorders or systemic vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-resolution CT scanningHigh-resolution CT scanning | Procedure or surgery | Renal transplant patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Buzio, MD principal investigator
University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplantation and Kidney-pancreas Transplantation, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2009.