Pharmacokinetic Study of Conversion Between 2 Formulations of Once-daily Extended-release Tacrolimus in Stable Lung Transplant Patients.

Abstract:

BACKGROUND:The aim of this study was to compare the pharmacokinetic profile, tolerability, and safety of a novel once-daily extended-release formulation of tacrolimus (LCPT) with that of once-daily prolonged-release tacrolimus (ODT) in stable adult lung transplant (LT) recipients. METHODS:Phase II, open-label, single-arm, single-center, prospective pilot pharmacokinetic study. Study population comprised 20 stable LT recipients receiving ODT, mean age 55.9 years (range, 38-67 years), 13 (65%) men. Patients were switched to LCPT in a 1:0.7 (mg/mg) conversion dose. Follow-up was 6 months, and cystic fibrosis patients were excluded. Two 24-hour pharmacokinetic profiles were obtained for each patient, the first on day -14 and the second on day +14 after switching to LCPT. Pharmacokinetic parameters and safety were compared. RESULTS:Mean (SD) area under the concentration-time curve from 0 to 24 hours was 253.97 (61.90) ng/mL per hour for ODT and 282.44 (68.2) ng/mL per hour for LCPT. Systemic exposure was similar in both (Schuirmann two 1-sided test). Mean (SD) dose was 5.05 (1.67) mg in ODT and 3.36 (1.03) mg in LCPT (P = 0.0002). Time to maximum concentration was 125 minutes for ODT and 325 minutes for LCPT (P < 0.001). Correlation between area under the concentration-time curve from 0 to 24 hours and C24 was 0.896 (r) for ODT and 0.893 (r) for LCPT. There were no differences in adverse effects. At 6 months, conversion dose was 1:0.59 (mg/mg) in patients with unchanged minimum plasma concentration target levels. CONCLUSIONS:Switching from ODT to LCPT was safe and well tolerated in stable LT recipients without cystic fibrosis. A significantly lower dose of LCPT allows similar bioavailability. A conversion ratio 1:0.6 could be enough to maintain similar target levels.

journal_name

Transplantation

journal_title

Transplantation

authors

Sintes H,Sáez-Giménez B,Berastegui C,López-Meseguer M,Monforte V,Bravo C,Vima J,Gómez-Ollés S,Roman A

doi

10.1097/TP.0000000000002348

subject

Has Abstract

pub_date

2018-10-01 00:00:00

pages

e439-e446

issue

10

eissn

0041-1337

issn

1534-6080

journal_volume

102

pub_type

杂志文章
  • Urine cytokines profile in renal transplant patients with asymptomatic bacteriuria.

    abstract:BACKGROUND:The role of asymptomatic bacteriuria in kidney transplant recipients is unknown. There is no clear evidence of its effect on transplanted kidney. METHODS:We studied urine cytokines profile among kidney transplant recipients with bacteriuria found in screening examination. Urine cultures were collected in 26...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000226072.20185.f8

    authors: Ciszek M,Paczek L,Bartłomiejczyk I,Mucha K

    更新日期:2006-06-27 00:00:00

  • CD4+CD45RO+CD25-/lowCD127+: CD4+CD45RO+CD25hiCD127-/low Ratio in Peripheral Blood: A Useful Biomarker to Detect Cardiac Allograft Vasculopathy in Heart Transplanted Patients.

    abstract:BACKGROUND:Cardiac allograft vasculopathy (CAV) is a major limitation in long-term graft survival after heart transplantation (HTx). Its prediction and detection at an early stage is a challenge because an accurate, minimally invasive blood test is lacking. The aim of this study was to analyze the relationship of Tact ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000000493

    authors: Roldán C,Mirabet S,Cecilia C,Brossa V,Roig E,Martín C,Gelpí C

    更新日期:2015-07-01 00:00:00

  • Lethal post-transplantation calcinosis.

    abstract::The case studies of four patients with post-transplantation calcinosis are presented. Three of the four patients died of inanition and sepsis secondary to infection of extensive soft tissue ulcers and diffuse cutaneous vascular calcification with gangrene. The fourth patient survived following removal of all four para...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-197901000-00006

    authors: Perloff LJ,Spence RK,Grossman RA,Barker CF

    更新日期:1979-01-01 00:00:00

  • Anti-human leukocyte antigen antibodies, vascular C4d deposition and increased soluble c4d in broncho-alveolar lavage of lung allografts.

    abstract:BACKGROUND:The hallmark of humoral rejection is the presence of subendothelial C4d in the allograft. A simultaneous determination of vascular C4d with soluble C4d in broncho-alveolar lavage fluid (BAL) and circulating anti-human leukocyte antigen (HLA) antibodies (HLA-Ab) has not been reported in lung transplantation. ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e31817cf2e2

    authors: Girnita AL,Lee TM,McCurry KR,Baldwin WM 3rd,Yousem SA,Detrick B,Pilewski J,Toyoda Y,Jelinek L,Lomago J,Zaldonis D,Spichty KJ,Zeevi A

    更新日期:2008-07-27 00:00:00

  • Correction of decreased guanylate cyclase activity in diabetic rats by pancreatic islet transplantation.

    abstract::We have previously demonstrated that streptozotocin-induced diabetic rats have decreased guanylate cyclase (EC 4.6.1.2) activity in liver and other tissues which was returned to normal by the administration of exogenous insulin. Since successful pancreatic islet transplants have been shown to lower basal hepatic gluco...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:

    authors: Vesely DL,Selawry H,Levey GS

    更新日期:1979-06-01 00:00:00

  • Variable allograft responses to pretreatment with donor splenocytes treated with mitomycin C in the rat.

    abstract::In an attempt to investigate the nonspecificity of the effect of administration of donor splenocytes treated with mitomycin C (MMC) 7 days before transplantation in inducing immunological unresponsiveness, the survival rates of liver, heart, small bowel, and skin allografts were compared in the RT1-incompatible ACI(RT...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198902000-00036

    authors: Yamaguchi Y,Harland R,Wyble C,Mori K,Bollinger RR

    更新日期:1989-02-01 00:00:00

  • Combined living donor liver/small bowel transplantation.

    abstract::We are reporting the first known case of sequential combined living donor liver/small bowel transplantation (LDL/SBT). A 2-year-old boy born with gastroschisis and intestinal malrotation lost his entire small bowel and colon shortly after birth. He underwent a living donor small bowel transplant at 1 year of age that ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000157280.75015.14

    authors: Testa G,Holterman M,John E,Kecskes S,Abcarian H,Benedetti E

    更新日期:2005-05-27 00:00:00

  • Ontogeny of suppressor cells. II. Suppression of graft-versus-host and mixed leukocyte culture responses by embryonic cells.

    abstract::Ontogenic development of suppressor cells was studied in mouse embryos. It was found that liver cells of embryos at various stages of gestation were capable of interfering with the mixed leukocyte culture (MLC) reaction. The MLC reaction was also inhibited by embryonic spleen and thymus cells. However, the latter were...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-197812000-00016

    authors: Globerson A,Umiel T

    更新日期:1978-12-01 00:00:00

  • Evaluation of pretransplant immunologic status in kidney-transplant recipients by panel reactive antibody and soluble CD30 determinations.

    abstract:OBJECTIVES:To retrospectively compare the accuracy of pretransplant panel of reactivity antibodies (PRA) and serum level of soluble CD30 (sCD30) in predicting early (< 6 months) acute rejection (AR) in living-donor and deceased-donor kidney-transplant (KT) patients. METHODS:Pretransplant sera of 24 KT recipients were ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:

    authors: Cinti P,Pretagostini R,Arpino A,Tamburro ML,Mengasini S,Lattanzi R,De Simone P,Berloco P,Molajoni ER

    更新日期:2005-03-15 00:00:00

  • Hepatic stellate cells preferentially expand allogeneic CD4+ CD25+ FoxP3+ regulatory T cells in an IL-2-dependent manner.

    abstract:BACKGROUND:Organ transplantation has been successfully practiced for decades, but the outcome of cell transplantation remains disappointing. This is the case in animal models; liver allografts in mice are spontaneously accepted without requirement of immunosuppression, whereas hepatocyte transplants in the same combina...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e31818bfd13

    authors: Jiang G,Yang HR,Wang L,Wildey GM,Fung J,Qian S,Lu L

    更新日期:2008-12-15 00:00:00

  • Results of renal transplantation in patients with renal cell carcinoma and von Hippel-Lindau disease.

    abstract:BACKGROUND:Patients with von Hippel-Lindau (VHL) disease are at risk for the development of end-stage renal failure from the treatment of localized renal cell carcinoma. Transplantation with its attendant immunosuppression may predispose patients to tumor recurrence; however, there is little information regarding the o...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199712270-00017

    authors: Goldfarb DA,Neumann HP,Penn I,Novick AC

    更新日期:1997-12-27 00:00:00

  • Role of ischemic preconditioning and the portosystemic shunt in the prevention of liver and lung damage after rat liver transplantation.

    abstract:BACKGROUND:This study evaluates whether surgical strategies such as the portosystemic shunt and ischemic preconditioning can protect against hepatic and pulmonary injury associated with liver transplantation. METHODS:The effect of the portosystemic shunt, ischemic preconditioning, and both surgical procedures together...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.TP.0000067529.82245.4E

    authors: Fernández L,Heredia N,Peralta C,Xaus C,Roselló-Catafau J,Rimola A,Marco A,Serafín A,Deulofeu R,Gelpí E,Grande L

    更新日期:2003-07-27 00:00:00

  • Inverse correlation of cyclosporine binding with sensitivity and resistance.

    abstract::The primary effects of CsA on human lymphocyte responses in vitro appear to be the inhibition of IL-2 production and the inhibition of cytotoxic T cell activation. Induction of suppressor T cell activity is resistant to the effects of CsA. These data imply two distinct subsets of lymphocytes: CsA-resistant and CsA-sen...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198808001-00012

    authors: Hess AD,Colombani PM

    更新日期:1988-08-01 00:00:00

  • Skin-autofluorescence is an independent predictor of graft loss in renal transplant recipients.

    abstract:BACKGROUND:Skin-autofluorescence (skin-AF) noninvasively measures the tissue accumulation of advanced glycation end products (AGEs). AGEs are nephrotoxic and potential effectors of cardiovascular mortality. We investigated whether skin-AF predicted graft loss after kidney transplantation. METHODS:A total of 302 renal ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e31819d3173

    authors: Hartog JW,Gross S,Oterdoom LH,van Ree RM,de Vries AP,Smit AJ,Schouten JP,Nawroth PP,Gans RO,van Son WJ,Bierhaus A,Bakker SJ

    更新日期:2009-04-15 00:00:00

  • Similar effects of cyclosporine and verapamil on lymphokine, interleukin 2 receptor, and proto-oncogene expression.

    abstract::Since calcium channel blocking agents and CsA exert an antiproliferative effect upon T cell mitogenesis, we have compared and characterized their immunosuppressive properties at the level of gene activation. Verapamil (greater than or equal to 30 microM), which blocks T cell mitogenesis and a rise in cytosolic calcium...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198902000-00029

    authors: Walz G,Zanker B,Wieder K,Hadro E,Moscovitch-Lopatin M,Smith BR,Strom TB

    更新日期:1989-02-01 00:00:00

  • Preventing acute rejection, Epstein-Barr virus infection, and posttransplant lymphoproliferative disorders after kidney transplantation: use of aciclovir and mycophenolate mofetil in a steroid-free immunosuppressive protocol.

    abstract:BACKGROUND:A widely held view is that any increase in the potency of an immunosuppressive agent will lead to an increase in infection and malignancy, such as life-threatening Epstein-Barr virus (EBV) induced posttransplant lymphoproliferative disorders (PTLD). We tested this paradigm by studying the effect of adding mo...

    journal_title:Transplantation

    pub_type: 临床试验,杂志文章

    doi:10.1097/00007890-199905150-00002

    authors: Birkeland SA,Andersen HK,Hamilton-Dutoit SJ

    更新日期:1999-05-15 00:00:00

  • Identification of kidneys subjected to preretrieval warm ischemic injury by simultaneous monitoring of glomerular filtration and perfusate flow during hypothermic perfusion preservation.

    abstract:BACKGROUND:Historically, ex vivo physiological evaluation of cadaveric renal allografts has been limited to assessing perfusate flow (PF) during hypothermic perfusion preservation (HPP). Using a small animal model, we have previously described a method for continuous monitoring of glomerular filtration rate (GFR) durin...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199911270-00006

    authors: Inman SR,Osgood RW,Plott WK,Richardson BF,Lewis RM

    更新日期:1999-11-27 00:00:00

  • Racial disparities in living kidney donation: is there a lack of willing donors or an excess of medically unsuitable candidates?

    abstract:BACKGROUND:Live kidney donation is safe for healthy donors and an effective treatment for patients with end-stage renal disease. Many potential donors are referred for live kidney donation, but only a small percentage donate. This study aims to determine reasons for nondonation and establish if racial differences exist...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000232693.69773.42

    authors: Lunsford SL,Simpson KS,Chavin KD,Menching KJ,Miles LG,Shilling LM,Smalls GR,Baliga PK

    更新日期:2006-10-15 00:00:00

  • Comparison of activation requirements and activation phenotype of allogeneic and xenogeneic rodent responses in vivo and in vitro.

    abstract:BACKGROUND:Both discordant and concordant xenogeneic responses are dominated by humoral immunity. Recent advances in molecular engineering approaches may largely prevent rejection by means of this pathway, leaving the cellular arm of the immune response as the principal remaining barrier to successful engraftment. MET...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-200108150-00021

    authors: Trani JL,Song HK,Lerner SM,Markmann JW,Barker CF,Naji A,Markmann JF

    更新日期:2001-08-15 00:00:00

  • Alteration in CD45RBhi/CD45RBlo T-cell ratio following CD45RB monoclonal-antibody therapy occurs by selective deletion of CD45RBhi effector cells.

    abstract::Tolerance induction by CD45RB monoclonal antibody (mAb) in murine allograft models is associated with an alteration in the CD45RBlo/CD45RBhi T-cell ratio in favor of CD45RBlo T cells, which can function as regulatory cells and promote tolerance. It has been proposed that inversion of the CD45RBhi/CD45RBlo normal T-cel...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.TP.0000072373.77323.D4

    authors: Luke PP,Deng JP,O'Brien CA,Everest M,Hall AV,Chakrabarti S,O'Connell PJ,Zhong R,Jevnikar AM

    更新日期:2003-07-27 00:00:00

  • Administration of hydrogen-rich saline protects mice from lethal acute graft-versus-host disease (aGVHD).

    abstract:BACKGROUND:Allogeneic hematopoietic stem cell transplantation is a potentially curative therapy for many malignant and nonmalignant hematologic diseases. However, acute graft-versus-host disease (aGVHD) is a lethal complication of hematopoietic stem cell transplantation, which limits its application. Cytokines such as ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e31827e6b23

    authors: Qian L,Mei K,Shen J,Cai J

    更新日期:2013-03-15 00:00:00

  • Benefit of phosphodiesterase 4 inhibitors as supplemental therapy after lung transplantation concerning their antiproliferative effects: an experimental study using a heterotopic rodent model.

    abstract:BACKGROUND:Recent advances in the understanding of immunomodulatory properties of phosphodiesterase 4 (PDE4) inhibitors recommend these drugs for immunosuppressive therapy after lung transplantation. The potency of three PDE4 inhibitors was tested using an established model of heterotopic tracheal transplantation in ra...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-200208150-00007

    authors: Schade I,Roth-Eichhorn S,Kasper M,Kuss H,Plötze K,Funk RH,Schüler S

    更新日期:2002-08-15 00:00:00

  • Ethnic disparity in clinical outcome after heart transplantation is abrogated using tacrolimus and mycophenolate mofetil-based immunosuppression.

    abstract:BACKGROUND:Black American heart transplant recipients receiving cyclosporine-based primary immunoprophylaxis suffer higher rates of allograft rejection with hemodynamic compromise, infections, and posttransplant coronary artery disease. We examined the hypothesis that a combination of tacrolimus and mycophenolate mofet...

    journal_title:Transplantation

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1097/00007890-200212150-00014

    authors: Mehra MR,Uber PA,Scott RL,Park MH

    更新日期:2002-12-15 00:00:00

  • LPS-induced Airway-centered Inflammation Leading to BOS-like Airway Remodeling Distinct From RAS-like Fibrosis in Rat Lung Transplantation.

    abstract:BACKGROUND:Localization of inflammatory stimuli may direct lung allografts to different phenotypes of chronic dysfunction, such as bronchiolitis obliterans syndrome (BOS) or restrictive allograft syndrome (RAS). We hypothesized that airway stimulation with lipopolysaccharide (LPS) in rats leads to airway-centered infla...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000003097

    authors: Takahagi A,Sato M,Chen-Yoshikawa TF,Miyamoto E,Saito M,Gochi F,Hamaji M,Yoshizawa A,Terasaki Y,Urushiyama H,Aoyama A,Sonobe M,Date H

    更新日期:2020-06-01 00:00:00

  • Pulmonary and blood stream infections in adult living donor and cadaveric liver transplant patients.

    abstract:BACKGROUND:Infectious complications occur in approximately 50% of cadaveric liver transplant (CDLT) recipients. Living-donor liver transplantation (LDLT) is an established alternative to shorten the waiting time. Currently, the incidence of pulmonary infections after LDLT and the microbiologic causes are unknown. In th...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e31816f61a6

    authors: Saner FH,Olde Damink SW,Pavlakovic G,van den Broek MA,Rath PM,Sotiropoulos GC,Radtke A,Canbay A,Paul A,Nadalin S,Malagó M,Broelsch CE

    更新日期:2008-06-15 00:00:00

  • Procurement of the human pancreas for pancreatic islet transplantation.

    abstract:BACKGROUND:The full potential of pancreatic islet transplantation (PIT) has not been realized because of the difficulties associated with islet isolation, particularly when associated with a remote islet isolation center. Herein, we describe the principles of pancreatic procurement for PIT, which have allowed us to ach...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000128910.41921.4b

    authors: Lee TC,Barshes NR,Brunicardi FC,Alejandro R,Ricordi C,Nguyen L,Goss JA

    更新日期:2004-08-15 00:00:00

  • Outcomes of African American kidney transplant recipients treated with sirolimus, tacrolimus, and corticosteroids.

    abstract:BACKGROUND:African American kidney transplant recipients generally exhibit poor long-term graft survival compared with other ethnic groups. The combination of sirolimus, tacrolimus, and corticosteroids has proven to be effective in reducing rejection episodes in high-risk organ and islet cell transplant recipients but ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-200207270-00008

    authors: Hricik DE,Anton HA,Knauss TC,Rodriguez V,Seaman D,Siegel C,Valente J,Schulak JA

    更新日期:2002-07-27 00:00:00

  • Prevention of graft-versus-host disease following small bowel transplantation with polyclonal and monoclonal antilymphocyte serum. The effect of timing and route of administration.

    abstract::Graft-versus-host disease is a potential problem following small bowel transplantation. We have previously shown that a two-day intraperitoneal course of polyclonal antilymphocyte serum completely prevents GVHD without impairing allograft function in a unidirectional rat small bowel transplant model. In the present st...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199112000-00002

    authors: Shaffer D,Ubhi CS,Simpson MA,Gottschalk R,Milford EL,Maki T,Monaco AP

    更新日期:1991-12-01 00:00:00

  • Prolongation of adult skin allograft survival by cotransplantation of neonatal skin in antilymphocyte serum and donor bone marrow cell-treated mice.

    abstract::Adult male B6AF1 (H-2KIb/kDb/d) mice were given skin allografts from adult male C3H (H-2k) mice, with and without contralateral cotransplants. The cotransplants were of either adult or neonatal (less than 24 hr) C3H skin. In recipient mice treated peritransplantation with antilymphocyte serum and posttransplantation w...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199012000-00001

    authors: Markees TG,De Fazio SR,Gozzo JJ

    更新日期:1990-12-01 00:00:00

  • Critical Ischemia Times and the Effect of Novel Preservation Solutions HTK-N and TiProtec on Tissues of a Vascularized Tissue Isograft.

    abstract:BACKGROUND:We herein investigate critical ischemia times and the effect of novel preservation solutions such as new histidine-tryptophan-ketoglutarate (HTK-N) and TiProtec on the individual tissues of a rat limb isograft. METHODS:Orthotopic hind-limb transplantations were performed in male Lewis rats after 2 hours, 6 ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000001845

    authors: Messner F,Hautz T,Blumer MJF,Bitsche M,Pechriggl EJ,Hermann M,Zelger B,Zelger B,Öfner D,Schneeberger S

    更新日期:2017-09-01 00:00:00