CE-US in Renal Transplantation

Status Completed

Clinical Trial Summary

Acute allograft dysfunction is often observed in the first weeks after kidney transplantation. Renal biopsy is universally considered the gold standard procedure for differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes. Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover, it may but not contribute to clinical diagnosis in about 10% of cases because of the impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or readily applicable non-invasive procedures might therefore allow increasing the performance of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a surrounding phospholipid monolayer and last for several minutes in the systemic circulation before spontaneous degradation with absorption of the gaseous component by the lungs and the phospholipid shell by the liver. With the use of gasfilled microbubbles that act as scatterers within the blood stream and the development of low-MI ultrasound techniques that allow the visualization of the bubbles without destroying them, it is possible to improve the depiction of vessels and have access to structural and functional information on the microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to evaluate kidney disfunction.

Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be associated with different patterns of renal graft involvement during acute renal function deterioration and b. whether, conversely, different patterns of parenchymal perfusion detected by CE-US may help predicting different patterns of renal involvement will be investigated in 20 deceased or living donor kidney graft recipients.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Renal Transplantation

Clinical Trial Details

NCT number	NCT01815320
Study type	Interventional
Source	Mario Negri Institute for Pharmacological Research
Contact
Status	Completed
Phase	Phase 2
Start date	April 2011
Completion date	September 2013

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06026592` - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Active, not recruiting	`NCT02444429` - 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation	Phase 3
Completed	`NCT02238418` - Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.	Phase 4
Completed	`NCT01729494` - Belatacept Early Steroid Withdrawal Trial	Phase 4
Terminated	`NCT01436305` - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation	Phase 2
Terminated	`NCT01276834` - Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation	Phase 4
Completed	`NCT02843295` - Catalytic Antibodies to Predict Uninvasively Late Transplant Failure	N/A
Completed	`NCT00842699` - Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab	N/A
Completed	`NCT00525681` - Interaction Between Rimonabant and Cyclosporine and Tacrolimus	Phase 4
Completed	`NCT00776750` - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients	Phase 4
Completed	`NCT00189735` - A Study to Evaluate FK778 in Kidney Transplant Patients	Phase 2
Recruiting	`NCT04052867` - Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy	N/A
Recruiting	`NCT03114826` - Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients	N/A
Completed	`NCT02587052` - A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
Completed	`NCT02020642` - Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)	N/A
Completed	`NCT01435291` - AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation	Phase 4
Recruiting	`NCT01001065` - Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis	N/A
Completed	`NCT00978965` - Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
Recruiting	`NCT00903188` - Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation	Phase 4
Completed	`NCT00400400` - Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance	Phase 4