Abstract:
:An exploratory, post hoc analysis was performed using data from a prospective, multicenter, open-label, randomized, two-period (14 d per period), two-sequence, crossover, steady-state pharmacokinetic study comparing generic tacrolimus (Sandoz) vs. reference tacrolimus in stable renal transplant patients receiving their pre-study twice-daily dose. Pharmacokinetic parameters were compared in 68 patients according to gender, African American ethnicity, the presence or absence of diabetes, and use of steroids. The ratios of tacrolimus AUC0-12 h , Cmax , and C12 with generic vs. reference tacrolimus were calculated using the geometric mean (GM) of dose-normalized values at days 14 and 28. Mean (SD) tacrolimus dose at baseline was 5.7 (4.2) mg/d. There were no consistent differences in dose-normalized AUC0-12 h , C12 , Cmax, or tmax between the generic and reference preparations within subpopulations. The 90% confidence intervals (CI) for the ratios of dose-normalized AUC0-12 h and C12 with generic vs. reference tacrolimus were within 80-125% for all subpopulations, as were 90% CIs for Cmax other than for females, African Americans, and non-diabetics, which is not unexpected given the wide variability of tacrolimus Cmax and the small subpopulation sizes. These exploratory results suggest that this generic tacrolimus preparation would be expected to offer comparable bioavailability to the reference drug in these patient subpopulations.
journal_name
Clin Transplantjournal_title
Clinical transplantationauthors
Bloom RD,Trofe-Clark J,Wiland A,Alloway RRdoi
10.1111/ctr.12256subject
Has Abstractpub_date
2013-11-01 00:00:00pages
E685-93issue
6eissn
0902-0063issn
1399-0012journal_volume
27pub_type
杂志文章,多中心研究,随机对照试验abstract::Stroke incidence is high in end-stage renal disease, and risk factors differ between the dialysis and general populations. However, risk factors and outcomes following renal transplantation remain unclear. We analyzed all adult patients with a functioning renal transplant from 01/01/2007 to 12/31/2012. Data were extra...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.12765
更新日期:2016-08-01 00:00:00
abstract:BACKGROUND:A questionnaire study was designed to determine whether the quality of life benefit provided by receiving a kidney-pancreas (KP) transplant increased the incentive to return to work, compared with patients receiving a kidney alone (KA) transplant. METHODS:A confidential questionnaire was sent to 58 patients...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2004.00115.x
更新日期:2004-02-01 00:00:00
abstract::Endoscopy with histopathological assessment is an established practice to confirm gastrointestinal graft-versus-host disease (GI-GVHD). However, the clinical relevance of this approach in children is incompletely evaluated. In a retrospective cohort study, we investigated the frequency of treatment changes in response...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.13867
更新日期:2020-07-01 00:00:00
abstract::The aim of this study was to improve outcomes in living donor liver transplantation (LDLT) patients with portal vein thrombosis (PVT). Of 246 adult patients who underwent LDLT with a right lobe graft between January 2000 and May 2007, PVT was diagnosed in 50 patients (20.3%), who were further subdivided into partial (...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2010.01217.x
更新日期:2011-01-01 00:00:00
abstract::Haploidentical stem cell transplantation (SCT) is increasingly used to treat pediatric patients with malignant or nonmalignant hematological disorders. The CD34+ dose of bone marrow or peripheral blood stem cells (PBSCs) has been shown to be an important determinant of the transplant outcome in adults under various pr...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.12880
更新日期:2017-02-01 00:00:00
abstract::This multicenter, randomized trial aimed to compare the safety and efficacy of an early reduction in corticosteroid dose vs. long-term maintenance in Brazilian patients on an immunosuppressive regimen based on tacrolimus and mycophenolate mofetil (MMF). In the control arm, prednisone was progressively reduced from day...
journal_title:Clinical transplantation
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1111/j.1399-0012.2009.01185.x
更新日期:2010-07-01 00:00:00
abstract:BACKGROUND:Cardiac allograft vasculopathy (CAV) limits survival after heart transplantation (HTx). Between immunologic and non-immunologic factors, reactive oxygen species generation has been proposed as pathogenetic mechanism. This study was aimed at evaluating redox status in HTx recipients and verifying whether it c...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2005.00352.x
更新日期:2005-06-01 00:00:00
abstract::Idiopathic interstitial pneumonia (IIP) can occur after stem cell transplantation, but the aetiology is unknown. Based on the association between angiitis syndrome and Helicobacter pylori infection, we identified possible risk factors common to these two conditions. Among 83 patients who underwent stem cell transplant...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1034/j.1399-0012.2003.00053.x
更新日期:2003-08-01 00:00:00
abstract::During liver transplant (LT), the release of vasoactive substances into the systemic circulation is associated with severe hemodynamic instability that is injurious to the recipient and/or the post-ischemic graft. Crystalloid flush with backward unclamping (CB) and portal blood flush with forward unclamping (PF) are t...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.12130
更新日期:2013-07-01 00:00:00
abstract::15-deoxyspergualin (DSG) is a novel immunosuppressant which has been shown to be effective in preventing and treating rejection in animal allo- and xenotransplant models. Preliminary clinical studies suggest that DSG is an effective antirejection agent. In our study, 4 patients with biopsy-proven rejection episodes th...
journal_title:Clinical transplantation
pub_type: 临床试验,杂志文章
doi:
更新日期:1994-04-01 00:00:00
abstract::In recent years, several researchers have unraveled the previously unrecognized effects of granulocyte colony-stimulating factor (G-CSF) on hematopoiesis and the immune cell functions of bone marrow in healthy donors. In human leukocyte antigen-matched or haploidentical transplant settings, available data have establi...
journal_title:Clinical transplantation
pub_type: 杂志文章,评审
doi:10.1111/j.1399-0012.2010.01298.x
更新日期:2011-01-01 00:00:00
abstract::Approximately 8-11% of all organ donors are classified by Public Health Service (PHS) as increased-risk. The proportion of PHS increased-risk donors is on the rise. At the University of Washington Medical Center, in 2014, the proportion of transplants from PHS increased-risk donors was 28% of liver transplants and 23%...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.12582
更新日期:2015-09-01 00:00:00
abstract::Histoplasma capsulatum is a dimorphic fungus that most often causes asymptomatic infection in the immunocompetent population. In immunocompromised patients, including solid organ transplant (SOT) and hematopoietic cell transplant (HCT) recipients, however, it is likely to cause severe life-threatening infection. Post-...
journal_title:Clinical transplantation
pub_type: 杂志文章,评审
doi:10.1111/ctr.13087
更新日期:2017-10-01 00:00:00
abstract:UNLABELLED:Since the first description by Ratner and collegues in 1996, laparoscopic live-donor nephrectomy is gaining wide acceptance in an attempt to minimize the donor morbidity, length of hospital stay and length of time to return to work. It is unknown whether multiple renal arteries pose additional problems with ...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1034/j.1399-0012.2001.00012.x
更新日期:2001-01-01 00:00:00
abstract::In live related renal transplant program, management of multiple renal arteries (MRA) is technically demanding and used to be considered a relative contraindication because of increased risk of vascular and urologic complications. We present a retrospective analysis of the outcome of grafts with MRA and suggest certai...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1034/j.1399-0012.2001.150209.x
更新日期:2001-04-01 00:00:00
abstract::The importance of the size of the infused marrow cell dose (MCD) was investigated in 274 patients undergoing allogeneic BMT between 1975 and 1990. Among those, 65 had acute myelogenous leukemia (AML), 79 acute lymphoblastic leukemia (ALL), 58 chronic myelogenous leukemia (CML) and 25 severe aplastic anemia (SAA). MC...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:
更新日期:1992-02-01 00:00:00
abstract:BACKGROUND:Renal transplantation is an excellent therapeutic alternative for end-stage renal diseases. Nevertheless, the cardiac function is often impaired in renal-transplant patients (RTR) and importantly determines their prognosis. Adrenomedullin (ADM), a peptide involved in cardiovascular homeostasis, is believed t...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2005.00486.x
更新日期:2006-05-01 00:00:00
abstract:INTRODUCTION:Previously, increasing age has been a part of the exclusion criteria used when determining eligibility for a pancreas transplant. However, the analysis of pancreas transplantation outcomes based on age groupings has largely been based on single-center reports. METHODS:A UNOS database review of all adult p...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.12407
更新日期:2014-09-01 00:00:00
abstract::Kidney transplantation offers longer survival, less morbidity and lower costs than dialysis. It is also believed to improve quality of life. The aim of this study was to compare prospectively the perceived health status (PHS) of dialyzed patients on a waiting list with kidney transplant recipients after transplantatio...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2009.01080.x
更新日期:2010-05-01 00:00:00
abstract::The presence of donor-derived hematopoietic cells in blood and various tissues of the organ recipients, termed allogeneic microchimerism, has been considered to play an essential role in establishment of organ acceptance. In this study, we prospectively determined the presence of peripheral blood microchimerism (PBM) ...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1034/j.1399-0012.2001.150308.x
更新日期:2001-06-01 00:00:00
abstract:BACKGROUND:Everolimus (EVL) and sirolimus (SRL) were introduced into immunosuppressive regimens, in an attempt to replace or reduce the dose of the nephrotoxic calcineurin inhibitors (CNI). In our institution, due to an administrative decision, conversion from SRL to EVL, was carried out, providing us the opportunity t...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2011.01446.x
更新日期:2011-07-01 00:00:00
abstract::Although many report intra-operative cardiac arrests (ICAs) in liver transplantation (LT), the incidence, major causes, and outcome remain unclear. We aimed to investigate retrospectively, the incidence, nature, and outcome of ICA in Asian population and to identify risk factors for ICA. Consecutive 1071 LTs in an ins...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.12085
更新日期:2013-03-01 00:00:00
abstract::This prospective study aimed at determining the ganciclovir exposure observed under a daily dosage of 450 mg valganciclovir routinely applied to kidney transplant recipients with a GFR above 25 mL/min at risk for cytomegalovirus (CMV) disease. Ganciclovir levels at trough (C(trough)) and at peak (C₃(h)) were measured ...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2009.01205.x
更新日期:2010-11-01 00:00:00
abstract:BACKGROUND:The Southeastern Kidney Transplant Coalition was created in 2010 to improve kidney transplant (KTx) rates in Georgia, North Carolina, and South Carolina. To identify dialysis staff-reported barriers to transplant, the Coalition developed a survey of dialysis providers in the region. METHODS:All dialysis uni...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.12693
更新日期:2016-04-01 00:00:00
abstract:INTRODUCTION:Conversion from calcineurin inhibitor (CI)-based maintenance immunosuppression to sirolimus (SRL)-based immunosuppression may be beneficial in selected renal transplant recipients. The purpose of this study was to evaluate the safety and efficacy of a daclizumab (DAC) bridge protocol in patients converted ...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2004.00220.x
更新日期:2004-01-01 00:00:00
abstract::This study evaluated the efficacy of primary endovascular stenting in cases of transplant renal artery stenosis (TRAS) from cadaver and non-heart-beating donor kidneys. Patients with TRAS (n = 13) from a single-centre transplant population (n = 476) were treated by primary percutaneous angioplasty and endovascular ste...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2006.00499.x
更新日期:2006-05-01 00:00:00
abstract::Proven Pneumocystis carinii pneumonia (PCP) occurred in 8 (5.2%) of 154 adult liver transplant recipients between January 1986 and December 1992. The interval between transplantation and PCP ranged from 69 to 131 days with a mean of 95 days (SD 20 days). The PaO2 breathing room air at diagnosis ranged from 40 mmHg to ...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:
更新日期:1994-12-01 00:00:00
abstract:AIM:Uncontrolled donation after cardiac death (uDCD) remains an underutilized source of kidney allografts in the United States. The objective of this study was to estimate the impact of the implementation of a uDCD program on transplantation rates and long-term survival for patients with end-stage renal disease (ESRD) ...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/ctr.13868
更新日期:2020-07-01 00:00:00
abstract::Measurement of indocyanine green plasma disappearance rate (PDR(ICG)) has been suggested as a meaningful liver function parameter. However, there are only very limited data concerning its value in the monitoring of graft dysfunction (GDF) and primary non-function (PNF) especially during molecular absorbent recirculati...
journal_title:Clinical transplantation
pub_type: 杂志文章
doi:10.1111/j.1399-0012.2007.00706.x
更新日期:2007-11-01 00:00:00
abstract::With the increased number of long-term survivors after liver transplantation, new-onset diabetes after transplantation (NODAT) is becoming more significant in patient follow-up. However, the incidence of new-onset diabetes after living-donor liver transplantation (LDLT) has not been well elucidated. The aim of this st...
journal_title:Clinical transplantation
pub_type: 临床试验,杂志文章
doi:10.1111/ctr.12103
更新日期:2013-05-01 00:00:00