Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696146
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-29
First Post:
2020-12-22
Brief Title:
Berinert C1INH vs Placebo for DGFIRI
Sponsor:
Cedars-Sinai Medical Center
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
A Phase III Double-Blind Placebo-Controlled Study Assessing Safety and Efficacy of Preoperative Renal Allograft Infusions of C1 Inhibitor Berinert Human C1INH vs Placebo Administration in Recipients of a Renal Allograft From Deceased High Risk Donors and Its Impact on Delayed Graft Function DGF and IschemiaReperfusion Injury IRI
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
This is a Phase III double-blind randomized placebo-controlled study assessing safety and limited efficacy of intraoperative C1INH 500Ukidney vs Placebo administered into the graft renal artery 1-2 hours prior to implantation in adult subjects receiving a deceased donor kidney allograft considered high-risk for development of DGF KDPI80 Once eligible patients are identified consented and have an acceptable kidney transplant offer they will be randomized by the Cedars-Sinai Research Pharmacy to receive study drug vs placebo Drug and placebo will be prepared by the Cedars-Sinai Research Pharmacy and conveyed to the operating room in a blinded manner The drug will be administered by the transplant surgeon in the OR in a blinded manner
Detailed Description:
Pre-operative infusion of C1INH into the renal allograft artery 1-2 hours prior to implantation will improve early graft function and reduce the rate of DGF requirements for dialysis graft survival and eGFR in patients receiving kidney allografts from high risk deceased donor compared to placebo
Early graft function has a long-term effect on graft survival Poor early graft function and DGF contributes to decreased short- and long-term patient and graft survival increased incidence of acute rejection prolonged hospitalization and higher costs of transplantation Although multiple factors contribute to the impaired graft function ischemia-reperfusion injury IRI is the underlying pathophysiology leading to poor early graft function and DGF A 35 incidence of DGF has remained constant over time despite significant improvements in immunosuppressive strategies and patient management This may be due to increased use of kidneys from extended-criteria andor non-heart-beating donors where even greater rates 60 of DGF have been reported
More than 94653 people are currently waiting for a kidney transplant in the United States UNOSorg 9302019 Of the 19360 kidney transplants performed in the US in 2018 20 were from DCD donors and 9 from donors of KDPI85 The USRDS reports that more than 50 of patients on the waiting list are willing to accept a kidney from an expanded-criteria donor KDPI 85 This study will seek to expand the use of high KDPI kidneys and reduce wastage by showing improved function after C1INH treatment
Patients who fulfill all IE criteria will be eligible to be enrolled into Study
I Study Group 40 patients
Treatment Arm I - KDPI 80 kidneys will be infused with one intrarenal dose of 500U of Berinert in OR prior to implantation into the recipient
Control Arm - KDPI 80 kidneys will be administered one intrarenal dose of normal saline NS in the OR in a volume identical to the volume of the dose of Berinert before implantation of kidney into the patient
Drug v placebo administration will be randomized 11 Drug preparation and randomization will be carried out in a blinded fashion by research pharmacist
Early graft function has a long-term effect on graft survival Poor early graft function and DGF contributes to decreased short- and long-term patient and graft survival increased incidence of acute rejection prolonged hospitalization and higher costs of transplantation Although multiple factors contribute to the impaired graft function ischemia-reperfusion injury IRI is the underlying pathophysiology leading to poor early graft function and DGF A 35 incidence of DGF has remained constant over time despite significant improvements in immunosuppressive strategies and patient management This may be due to increased use of kidneys from extended-criteria andor non-heart-beating donors where even greater rates 60 of DGF have been reported
More than 94653 people are currently waiting for a kidney transplant in the United States UNOSorg 9302019 Of the 19360 kidney transplants performed in the US in 2018 20 were from DCD donors and 9 from donors of KDPI85 The USRDS reports that more than 50 of patients on the waiting list are willing to accept a kidney from an expanded-criteria donor KDPI 85 This study will seek to expand the use of high KDPI kidneys and reduce wastage by showing improved function after C1INH treatment
Patients who fulfill all IE criteria will be eligible to be enrolled into Study
I Study Group 40 patients
Treatment Arm I - KDPI 80 kidneys will be infused with one intrarenal dose of 500U of Berinert in OR prior to implantation into the recipient
Control Arm - KDPI 80 kidneys will be administered one intrarenal dose of normal saline NS in the OR in a volume identical to the volume of the dose of Berinert before implantation of kidney into the patient
Drug v placebo administration will be randomized 11 Drug preparation and randomization will be carried out in a blinded fashion by research pharmacist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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