Skip to main content
Clinical Trials/NCT01017757
NCT01017757
Unknown
Not Applicable

Cross-sectional Analysis of Subclinical Interstitial Lung Abnormalities in Stable Renal Transplant Recipients by High-resolution CT Scan

University of Parma1 site in 1 country63 target enrollmentJune 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Transplantation
Sponsor
University of Parma
Enrollment
63
Locations
1
Primary Endpoint
Subclinical lung alterations as assessed by high-resolution CT scanning
Last Updated
16 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
November 2009
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
Evaluation of the Impact of Tacrolimus-based Immunosuppression on Heidelberg Liver Transplant Cohort (HDTACRO): Study Protocol for an Investigator Initiated, Non-interventional Prospective StudyLiver Transplantation
NCT04444817University Hospital Heidelberg100
Completed
Phase 2
Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell TransplantAdult Acute Lymphoblastic LeukemiaAdult Acute Myeloid LeukemiaAdult Diffuse Large B-Cell LymphomaAdult Myelodysplastic SyndromeAdult Non-Hodgkin LymphomaAggressive Non-Hodgkin LymphomaChildhood Acute Lymphoblastic LeukemiaChildhood Acute Myeloid LeukemiaChildhood Diffuse Large B-Cell LymphomaChildhood Myelodysplastic SyndromeChildhood Non-Hodgkin LymphomaChronic Lymphocytic LeukemiaChronic Lymphocytic Leukemia in RemissionChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveHematopoietic and Lymphoid Cell NeoplasmMantle Cell LymphomaPlasma Cell MyelomaProlymphocytic LeukemiaRecurrent Chronic Lymphocytic LeukemiaRefractory Chronic Lymphocytic LeukemiaT-Cell Prolymphocytic LeukemiaWaldenstrom MacroglobulinemiaRecurrent Diffuse Large B-Cell LymphomaRecurrent Hodgkin Lymphoma
NCT01251575Fred Hutchinson Cancer Center77
Completed
Not Applicable
Microsampling Assays for Immunosuppressive Drugs in ChildrenImmunosuppression
NCT04989686Children's Hospital of Philadelphia66
Completed
Phase 4
Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant RecipientsHeart Transplantation
NCT00170859Novartis Pharmaceuticals
Active, not recruiting
Phase 1
ElucidatiNg Immunosuppressant pharmacokinetic variabilities by investigating Gut Microbiota modulations After kidney transplantation - ENIGMAChronic renal failureMedDRA version: 21.1Level: LLTClassification code: 10077912Term: Renal retransplantation Class: 10042613MedDRA version: 21.1Level: LLTClassification code: 10009119Term: Chronic renal failure Class: 10038359Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
CTIS2023-508335-31-00niversite Catholique de Louvain50