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Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its prevention is essential as it impedes early- and long-term prognosis of transplantation. Numerous pharmacological interventions aiming to prevent ischemia-reperfusion injuries failed to reduce the rate of DGF. We hypothesize that cyclosporine as an early preconditioning procedure in donors would be associated with decreased DGF. METHODS:The Cis-A-rein study is an investigator-initiated, prospective, multicenter, double-blind, randomized, controlled study performed to assess the effects of a donor preconditioning with cyclosporine A on kidney grafts function in transplanted patients. After randomization, a brain dead donor will receive 2.5 mg kg-1 of cyclosporine A or the same volume of 5% glucose solution. The primary objective is to compare the rate of DGF, defined as the need for at least one dialysis session within the 7 days following transplantation, between both groups. The secondary objectives include rate of slow graft function, mild and severe DGF, urine output and serum creatinine during the first week after transplantation, rate of primary graft dysfunction, renal function and mortality at 1 year. The sample size (n =?648) was determined to obtain 80% power to detect a 10% difference for rate of DGF at day 7 between the two groups (30% of the patients in the placebo group and 20% of the patients in the intervention group). DISCUSSION:Delayed graft function is a major issue after renal transplantation, impeding long-term prognosis. Cyclosporine A pretreatment in deceased donors could improve the outcome of patients after renal transplantation. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02907554 Registered on 20 September 2016.

SUBMITTER: Orban JC

PROVIDER: S-EPMC5905107 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial.

Orban Jean-Christophe JC Fontaine Eric E Cassuto Elisabeth E Baumstarck Karine K Leone Marc M Constantin Jean-Michel JM Ichai Carole C

Trials 20180417 1

<h4>Background</h4>Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its prevention is essential as it impedes early- and long-term prognosis of transplantation. Numerous pharmacological interventions aiming to prevent ischemia-reperfusion injuries failed to reduce the rate of DGF. We hypothesize that cyclosporine as an early preconditioning proced ...[more]

PMID: 29665840

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Project description:INTRODUCTION:Research on the management of deceased organ donors aims to improve the number and quality of transplants and recipient outcomes. In Canada, this research is challenged by regionalisation of donation services within provinces and the geographical, clinical and administrative separation of donation from transplantation services. This study aims to build a national platform for future clinical trials in donor management. Objectives are to engage collaborators at donation hospitals and organ donation organisations (ODOs) across Canada, describe current practices, evaluate the effectiveness of donation-specific interventions and assess the feasibility of future clinical trials. METHODS AND ANALYSIS:This ongoing prospective observational study of the medical management of deceased organ donors will enrol more than 650 consented potential donors from adult intensive care units at 33 hospital sites across Canada, each participating for 12 months. ODOs ensure enrolment of consecutive eligible participants. Research staff record detailed data about participants, therapies, organ assessments, death declaration procedures and adverse clinical exposures from the time of donation consent to organ recovery. ODOs provide reasons that organs are declined, dates and places of transplantation, and recipient age and sex.Descriptive analyses will summarise current practices. Effectiveness analyses will examine donation-specific interventions with respect to the number of transplants, using multilevel regression models to account for clustering by donor, hospitals and ODOs. Feasibility analyses will focus on acceptance of the research consent model; participation of academic and community hospitals as well as ODOs; and accessibility of recipient data. ETHICS AND DISSEMINATION:This study uses a waiver of research consent. Hospitals will receive reports on local practices benchmarked to (1) national practices and (2) national donor management guidelines. We will report findings to donation and transplant collaborators (ie, clinicians, researchers, ODOs) and publish in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03114436.

Project description:BackgroundPediatric deceased donors offer great potential for expanding the organ donor pool. The utilization of pediatric donor kidneys has been explored by numerous transplant centers; however, the transplant outcome and risk factors have not been well elucidated. The aim of this study was to demonstrate the safety and risk factors of transplant outcome from pediatric deceased donors.MethodsWe retrospectively analyzed 484 cases of single kidney transplantation (SKT) with pediatric donor kidneys performed at our center from January 2012 to March 2021. The recipients were grouped by age: child (≤12 years; n=143), adolescents (12-18 years; n=86), and adults (≥18 years; n=255). The overall prognosis of the recipients was analyzed, and the post-transplant outcomes were compared among the three groups and assessed by univariate and multivariate analyses using the Cox proportional risk model.ResultsThe median follow-up time was 26.7 months. The 1- and 3-year patient survival rates were 98.7% and 96.8%, respectively. The 1- and 3-year death-censored graft survival (DCGS) was 96.1% and 92.7%, respectively. The overall estimated glomerular filtration rates (eGFRs) at 1 and 3 years were 80.0±24.5 and 84.2±25.2 mL/min/1.73 m2; the 3-year eGFR of the three groups were comparable and all were over 80 mL/min/1.73 m2. Rejection was an independent risk factor for death-censored graft failure within 3 years after transplantation [hazard ratio (HR) =3.85; P=0.001], and was the primary cause of graft losses in the adolescent group. Thrombosis was more common within 1-month post-transplant in the child recipients (P<0.05), and its incidence was higher in recipients with donor body weight (DBW) ≤11 kg.ConclusionsSKT from pediatric donors could achieve decent outcomes. Rejection was an independent risk factor of graft survival, especially for adolescent recipients. Child recipients may compromise early transplant outcomes due to vascular thrombosis, which might be related to small (DBW ≤11 kg) pediatric donors.

Project description:BACKGROUND AND OBJECTIVES:The fraction of kidneys procured for transplant that are discarded is rising in the United States. Identifying donors from whom only one kidney was discarded allows us to control for donor traits and better assess reasons for organ discard. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:We conducted a retrospective cohort study using United Network for Organ Sharing Standard Transplant Analysis and Research file data to identify deceased donors from whom two kidneys were procured and at least one was transplanted. Unilateral pairs were defined as kidney pairs from a single donor from whom one kidney was discarded ("unilateral discard") but the other was transplanted ("unilateral transplant"). Organ quality was estimated using the Kidney Donor Risk Index and Kidney Donor Profile Index (KDPI). We compared all-cause graft failure rates for unilateral transplants to those for bilateral transplant Kaplan-Meier methods, and life table methodology was used to evaluate 1-, 2-, 3-, and 5-year survival rates of transplants from bilateral and unilateral donors. RESULTS:Compared with bilateral donors (i.e., both kidneys transplanted) (n=80,584), unilateral donors (i.e., only one kidney transplanted) (n=7625) had higher mean terminal creatinine (1.3±2.1 mg/dl versus 1.1±0.9 mg/dl) and KDPI (67%±25% versus 42%±27%), were older, and were more likely to have hypertension, diabetes, hepatitis C, terminal stroke, or meet Centers for Disease Control and Prevention high-risk donor criteria. Unilateral discards were primarily attributed to factors expected to be similar in both kidneys from a donor: biopsy findings (22%), no interested recipient (13%), and donor history (7%). Anatomic abnormalities (14%), organ damage (11%), and extended ischemia (6%) accounted for about 30% of discards, but were the commonest reasons among low KDPI kidneys. Among kidneys with KDPI?60%, there was an incremental difference in allograft survival over time (for unilateral versus bilateral transplants, 1-year survival: 83% versus 87%; 3-year survival: 69% versus 73%; 5-year survival: 51% versus 58%). CONCLUSIONS:A large number of discarded kidneys were procured from donors whose contralateral kidneys were transplanted with good post-transplant outcomes.

Dataset Information

Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial.

Publications

Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial.

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