Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-10
Brief Title:
1 vs 7 RATG Infusions in Renal Transplantation
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
Basiliximab With One Day or Seven Days RATG Induction Therapy in Renal Transplantation a Matched-cohort Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONSET
Brief Summary:
This trial is to compare the riskbenefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with basiliximab and steroid progressively tapered post-transplant and maintenance therapy with calcineurin inhibitors and mycophenolate mofetilmycophenolic acid in 75 recipients 25 Patients and 50 Reference-Patients of a single or dual first kidney transplant from an ideal or marginal donor at a single Renal Transplant Center
Detailed Description:
In patients receiving a kidney transplant it is necessary to use immunosuppressive drugs that serve to reduce or prevent the risk of rejection Some of these drugs are infused only in the first days of the transplant to more effectively reduce the reactivity of the immune system when the risk of rejection is highest Among these are thymoglobulins antibodies that destroy immune system cells lymphocytes which can cause rejection For this reason in their Center the investigators have developed a protocol that provides for the infusion of thymoglobulins for seven consecutive days starting from the day of the transplant The first infusion begins even before the transplant is performed so that the lymphocytes are destroyed before the kidney is implanted and can therefore be recognized by the immune system as a foreign organ This first administration is therefore certainly the most important to the point that perhaps subsequent infusions of thymoglobulins may not even be necessary Based on this reasoning starting from April 1st 2023 the investigators began to infuse only the first dose of thymoglobulins always starting the infusion before the transplant was performed avoiding subsequent administrations The goal was to maintain the same anti-rejection efficacy but reducing the risk of side effects In fact thymoglobulins reduce the number of white blood cells and platelets in the blood and can increase the risk of opportunistic infections which are facilitated by the fact that the activity of the immune system is reduced by thymoglobulins In other words the effects of thymoglobulins on the immune system that serve to reduce the risk of rejection are the same as those that increase the risk of infections
At this point the investigators would therefore like to verify whether actually infusing a single dose of thymoglobulin starting before the transplant can maintain the same anti-rejection effect that is obtained by administering seven doses of thymoglobulin while reducing the risk of side effects For this reason in this study they want to compare the data already collected for clinical reasons in kidney transplant recipients treated with a single dose of thymoglobulin with the data also already collected in kidney transplant recipients who instead received all seven doses of thymoglobulin The latter must have the same characteristics as patients who have received a single dose of thymoglobulins In essence the investigators should compare two groups of patients who are very similar in terms of the type of transplant performed for example single or double and the other anti-rejection therapies administered in addition to thymoglobulins and who differ only in having received one or seven infusions All patients will have received the transplant from the same surgical team and will have been monitored and treated by the same nephrology team based on the same standardized clinical monitoring and immunosuppressive treatment protocols regardless of the number of thymoglobulin doses In this way any differences in the risk of rejection or side effects that may emerge between the two groups could only be explained by the difference in treatment with thymoglobulins with a single dose or with seven doses
At this point the investigators would therefore like to verify whether actually infusing a single dose of thymoglobulin starting before the transplant can maintain the same anti-rejection effect that is obtained by administering seven doses of thymoglobulin while reducing the risk of side effects For this reason in this study they want to compare the data already collected for clinical reasons in kidney transplant recipients treated with a single dose of thymoglobulin with the data also already collected in kidney transplant recipients who instead received all seven doses of thymoglobulin The latter must have the same characteristics as patients who have received a single dose of thymoglobulins In essence the investigators should compare two groups of patients who are very similar in terms of the type of transplant performed for example single or double and the other anti-rejection therapies administered in addition to thymoglobulins and who differ only in having received one or seven infusions All patients will have received the transplant from the same surgical team and will have been monitored and treated by the same nephrology team based on the same standardized clinical monitoring and immunosuppressive treatment protocols regardless of the number of thymoglobulin doses In this way any differences in the risk of rejection or side effects that may emerge between the two groups could only be explained by the difference in treatment with thymoglobulins with a single dose or with seven doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None