Milano, Italy
Milano, Italy

Time filter

Source Type

Ponticelli C.,Humanitas Scientific Institute | Carmellini M.,Chirurgia Dei Trapianti Azienda Ospedaliera Universitaria | Tisone G.,University of Rome Tor Vergata | Sandrini S.,U.O. Nefrologia | And 4 more authors.
Transplantation Proceedings | Year: 2014

This multicenter, randomized, prospective, controlled trial (EVIDENCE study) aimed to determine short-term effects of early steroid withdrawal in renal transplant patients initially treated with everolimus, low-dose cyclosporine (CsA), and steroids. Patients were randomized to standard triple therapy with CsA, everolimus twice daily and steroids (group A), steroid-free immunosuppression (group B), or triple therapy once daily (group C). However, since patient enrollment was slower than expected, group C randomization was prematurely discontinued. The primary end point was treatment failure rate (composite end point of death, graft loss, biopsy-proven acute rejection, and loss to follow-up) between randomization and month 12. Patients evaluable for the primary end point included 139 randomized patients. According to intention-to-treat analysis, 2.8% of patients in group A and 14.7% in group B experienced treatment failure (95% upper confidence limit 19.7%). As this was higher than the predefined noninferiority limit of 10%, noninferiority could not be proved. No conclusive statements can be made on noninferiority of the steroid withdrawal regimen vs the standard regimen in these patients. Additional studies with longer follow-up are required to determine the efficacy of steroidfree immunosuppression in renal transplant recipients receiving everolimus.


PubMed | Humanitas Scientific Institute, Chirurgia dei Trapianti Azienda Ospedaliera Universitaria, University of Bologna, SSD Trapianti e Pancreas and 4 more.
Type: Journal Article | Journal: Transplantation proceedings | Year: 2014

This multicenter, randomized, prospective, controlled trial (EVIDENCE study) aimed to determine short-term effects of early steroid withdrawal in renal transplant patients initially treated with everolimus, low-dose cyclosporine (CsA), and steroids. Patients were randomized to standard triple therapy with CsA, everolimus twice daily and steroids (groupA), steroid-free immunosuppression (group B), or triple therapy once daily (groupC). However, since patient enrollment was slower than expected, group C randomization was prematurely discontinued. The primary end point was treatment failure rate (composite end point of death, graft loss, biopsy-proven acute rejection, and loss to follow-up) between randomization and month 12. Patients evaluable for the primary end point included 139 randomized patients. According to intention-to-treat analysis, 2.8% of patients in group A and 14.7% in group B experienced treatment failure (95% upper confidence limit 19.7%). As this was higher than the predefined noninferiority limit of 10%, noninferiority could not be proved. No conclusive statements can be made on noninferiority of the steroid withdrawal regimen vs the standard regimen in these patients. Additional studies with longer follow-up are required to determine the efficacy of steroid-free immunosuppression in renal transplant recipients receiving everolimus.


Minetti E.,Science Nefrologia
Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia | Year: 2010

Combined kidney-pancreas transplant is currently the best treatment option for patients with type 1 diabetes associated with chronic renal failure. The favorable results of simultaneous pancreas-kidney transplants (SPK), introduced in the early 1990s, led to the introduction of the pancreas after kidney transplant (PAK) and the pancreas transplant alone (PTA), a good option for patients with uncontrolled diabetes. The superior results of SPK over PAK are partly related to better donor selection and partly to immunological factors. In conclusion, PAK transplant is a good preemptive choice for patients for whom a living kidney donor is available, so that long-term uremia while the patient is waiting for a cadaver pancreas graft can be avoided. Despite a high surgical complication rate in all types of pancreas transplant (SPK, PAK, PTA), patient survival is good and graft survival is improving year by year.


Busnach G.,Science Nefrologia
Giornale italiano di nefrologia : organo ufficiale della Società italiana di nefrologia | Year: 2012

Patients who are sensitized through pregnancy, previous blood transfusions, or organ transplantation produce donor-specific anti-HLA antibodies (DSA) that can result in an important obstacle in kidney transplantation. Sensitized patients wait longer on the cadaver donor transplant list, may not receive a transplant, and may have greater morbidity and mortality. Sensitized patients may have living donor candidates but transplantation cannot be performed because of cross-match positivity. Kidney transplant recipients with DSA are at higher risk of developing early acute antibody-mediated rejection (AMR) despite negative complement-dependent cytotoxicity (CDC) T-cell cross-match, and thus require desensitization. Desensitization protocols using the combination of apheresis (PE) or immunoadsorption to remove DSA and/or intravenous Ig (Iv-Ig) and rituximab to downregulate antibody-mediated immune responses have made kidney transplantation feasible by abrogating CDC T-cell cross-match positivity. All sensitized patients should be studied for DSA by sensitive methods and followed over time. The presence of DSA should be documented, and also the strength or titers of the alloantibodies should be determined to decide on the type of desensitization protocol. High-dosage Iv-Ig alone does not prevent AMR in patients with strong DSA, and the addition of peritransplantation PE as unselective plasma exchange, semiselective double filtration, or selective immunoadsorption significantly decreases the incidence of AMR. The effect of addition of monoclonal antibodies such as rituximab to desensitization protocols or of PE to patients with strong anti-HLA-II DSA on allograft outcomes requires further prospective studies.


PubMed | Science Nefrologia
Type: | Journal: Giornale italiano di nefrologia : organo ufficiale della Societa italiana di nefrologia | Year: 2012

Patients who are sensitized through pregnancy, previous blood transfusions, or organ transplantation produce donor-specific anti-HLA antibodies (DSA) that can result in an important obstacle in kidney transplantation. Sensitized patients wait longer on the cadaver donor transplant list, may not receive a transplant, and may have greater morbidity and mortality. Sensitized patients may have living donor candidates but transplantation cannot be performed because of cross-match positivity. Kidney transplant recipients with DSA are at higher risk of developing early acute antibody-mediated rejection (AMR) despite negative complement-dependent cytotoxicity (CDC) T-cell cross-match, and thus require desensitization. Desensitization protocols using the combination of apheresis (PE) or immunoadsorption to remove DSA and/or intravenous Ig (Iv-Ig) and rituximab to downregulate antibody-mediated immune responses have made kidney transplantation feasible by abrogating CDC T-cell cross-match positivity. All sensitized patients should be studied for DSA by sensitive methods and followed over time. The presence of DSA should be documented, and also the strength or titers of the alloantibodies should be determined to decide on the type of desensitization protocol. High-dosage Iv-Ig alone does not prevent AMR in patients with strong DSA, and the addition of peritransplantation PE as unselective plasma exchange, semiselective double filtration, or selective immunoadsorption significantly decreases the incidence of AMR. The effect of addition of monoclonal antibodies such as rituximab to desensitization protocols or of PE to patients with strong anti-HLA-II DSA on allograft outcomes requires further prospective studies.


PubMed | Science Nefrologia
Type: | Journal: Giornale italiano di nefrologia : organo ufficiale della Societa italiana di nefrologia | Year: 2010

Combined kidney-pancreas transplant is currently the best treatment option for patients with type 1 diabetes associated with chronic renal failure. The favorable results of simultaneous pancreas-kidney transplants (SPK), introduced in the early 1990s, led to the introduction of the pancreas after kidney transplant (PAK) and the pancreas transplant alone (PTA), a good option for patients with uncontrolled diabetes. The superior results of SPK over PAK are partly related to better donor selection and partly to immunological factors. In conclusion, PAK transplant is a good preemptive choice for patients for whom a living kidney donor is available, so that long-term uremia while the patient is waiting for a cadaver pancreas graft can be avoided. Despite a high surgical complication rate in all types of pancreas transplant (SPK, PAK, PTA), patient survival is good and graft survival is improving year by year.

Loading Science Nefrologia collaborators
Loading Science Nefrologia collaborators