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A phase I/II, double-blind, placebo-controlled study assessing safety and efficacy of C1 esterase inhibitor for prevention of delayed graft function in deceased donor kidney transplant recipients.
- Source :
-
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons [Am J Transplant] 2018 Dec; Vol. 18 (12), pp. 2955-2964. Date of Electronic Publication: 2018 May 14. - Publication Year :
- 2018
-
Abstract
- Delayed graft function (DGF) is defined as need for dialysis early posttransplant. DGF is related to ischemia-reperfusion injury (IRI) that diminishes allograft function and may be complement dependent. Here, we investigate the ability of C1 esterase inhibitor (C1INH) to prevent IRI/DGF in kidney transplant recipients. Seventy patients receiving deceased donor kidney transplants at risk for DGF were randomized to receive C1INH 50 U/kg (#35) or placebo (#35) intraoperatively and at 24 hours. The primary end point was need for hemodialysis during the first week posttransplant. Assessments of glomerular filtration rate and dialysis dependence were accomplished. Complications and safety of therapy were recorded. Similar characteristics with no significant differences in cold-ischemia time or risk factors for DGF were seen. C1INH did not result in reduction of dialysis sessions at 1 week posttransplant, but significantly fewer dialysis sessions (P = .0232) were required 2 to 4 weeks posttransplant. Patients at highest risk for DGF (Kidney Donor Profile Index ≥85) benefited most from C1INH therapy. Significantly better renal function was seen at 1 year in C1INH patients (P = .006). No significant adverse events were noted with C1INH. Although the primary end point was not met, significant reductions in need for dialysis and improvements in long-term allograft function were seen with C1INH treatment.<br /> (© 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.)
- Subjects :
- Adolescent
Adult
Aged
Complement Inactivating Agents therapeutic use
Death
Delayed Graft Function etiology
Double-Blind Method
Female
Follow-Up Studies
Glomerular Filtration Rate
Graft Rejection etiology
Humans
Kidney Function Tests
Male
Middle Aged
Postoperative Complications etiology
Prognosis
Risk Factors
Tissue Donors
Young Adult
Complement C1 Inhibitor Protein therapeutic use
Delayed Graft Function drug therapy
Graft Rejection drug therapy
Graft Survival drug effects
Kidney Failure, Chronic surgery
Kidney Transplantation adverse effects
Postoperative Complications drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1600-6143
- Volume :
- 18
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
- Publication Type :
- Academic Journal
- Accession number :
- 29637714
- Full Text :
- https://doi.org/10.1111/ajt.14767