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76 protocols using prograf

1

Immunotherapeutic Modulation of Th1/Th2 Cytokines

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Example 6

0.1×106 lymphocytes were incubated with a mix of Th1 cytokine (IFN-γ and IL-2) or Th2 cytokine (IL-4, IL-5, and IL-10) capture microparticles (8,000/each with different fluorescent ID codes) in control media or the conditioned media containing various types of immunotherapeutic agents (Solumedrol 100 μM, Pharmacia & Upjohn Co.; Sirolimus 500 ng/mL, Wyeth pharmaceuticals Inc.; Prograf 100 ng/mL, Astellas Pharma US, Inc.; Infliximab 1 mg/mL, Janssen Biotech, Inc.) at 37° C. in a 5% CO2 incubator for 16 h with and without adding PHA or P+I (50 ng/mL of PMA+1 μg/mL of lonomycin). The cells were lysed with lysis buffer (50 mM Tris-HCl pH 7.4, 150 mM NaCl, 2 mM EDTA, 1% NP-40) and washed three times with 3% HBSA wash buffer (3% Bovine Serum Albumin in Hank's Balanced Salt Solution), the capture microparticles were then incubated with 50 μL detection antibodies mix (PE-anti-INF-γ, PE-anti-IL-2, PE-anti-IL-4, PE-anti-IL-5 and PE-anti-IL-10) from BD Bioscience at RT for 1 h with shaking. After three more washes, the microparticles were acquired and analyzed on a BD FACSCanto II flow cytometer. The result was expressed as a percentage of each of the different positive cytokine capture microparticles. FIG. 10-FIG. 14 depict the differential effects of the immunotherapeutic agents on the secretion of Th1 and Th2 cytokines.

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2

Triple-Therapy Immunosuppression Protocol

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The immunosuppressive protocol at our institution consists of a triple-drug therapy consisting of tacrolimus, mycophenolate mofetil (MMF), and steroids. Induction therapy included basiliximab 20 mg (Simulect®, Novartis) at day 0 and day 4 after transplantation, 500 mg intravenous (IV) methylprednisolone (Solu Medrol®: Pfizer) pre and 12 h post-operation. Oral tacrolimus (Prograf®, Astellas Pharma) was started at night 1 day before transplantation with a dose of 0.1 mg/kg/day administered in two divided doses. Subsequent doses were adjusted based on clinical evaluation and Tac levels. Mycophenolate mofetil (Cellcept®, Roche) was started with tacrolimus at a dose of 1 g twice a day and adjusted to lower doses in the presence of diarrhea or prolonged fever. The next IV dose of steroid decreased by half in consecutive days to 40 mg/day within one to two weeks post-transplant. Oral prednisolone (15 mg/day) was initiated right after and was tapered every week to a stable period of 5 mg/day.
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3

Immunosuppressant Regimen for Kidney Transplant

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We administered basiliximab (Simulect, 20 mg on days 0 and 4; Novartis, Basel, Switzerland) for KTRs with low immunologic risk and antithymocyte globulin (Thymoglobulin, 1.5 mg/kg on day 0 and 1.0 mg/kg from day 1 to day 3; Genzyme, Cambridge, MA, USA) for KTRs with high immunologic risk as induction immunosuppressants. We administered cyclosporine (Sandimmune, 3 mg/kg, twice a day; Novartis AG, Basel, Switzerland) or tacrolimus (Prograf, 0.05 mg/kg, twice a day; Astellas Pharma Inc., Toyama, Japan) as a CNI, prednisolone (30 – 20 – 10 – 5 – 0 mg, once a day, on a stepdown regimen), and mycophenolate mofetil (CellCept, 750 or 1,000 mg, twice a day for 1 month after KT and subsequent 500 mg, twice a day; Hoffmann-La Roche Inc., Nutley, NJ, USA) as maintenance immunosuppressants. The treatment protocol for recurrent IgAN was use of an angiotensin receptor blocker at diagnosis; if it elicited no response, then 0.25 mg/kg per day of oral steroid was used.
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4

Tacrolimus Conversion in Liver Transplant

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A prospective, observational, cohort study (NCT02143479) was undertaken in 18 centers in France that included liver transplant recipients who converted from twice-daily immediate-release tacrolimus (Prograf®, Astellas Pharma Ltd., Chertsey, UK) to once-daily prolonged-release tacrolimus (Advagraf®, Astellas Pharma Europe BV, Netherlands). The study was conducted in accordance with the relevant ethical standards, approved by the local advisory committee (CCTIRS) and was authorized by the French National Commission for Data Processing and Privacy (CNIL) (authorization No. DR-2014-136). All study participants provided informed consent and were free to withdraw from the study at any stage.
Stable liver transplant recipients (≥18 years) who had undergone transplantation in the preceding 12 months, were eligible for inclusion in the study if their physician had decided to convert them from immediate-release to prolonged-release tacrolimus according to the usual medical practice at a previously scheduled appointment. The only exclusion criterion was concomitant participation in any other international clinical study.
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5

Kidney Transplant Immunosuppressive Regimen

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The typical immunosuppressive regimen at our institute was described previously.[9 (link)] All kidney recipients receive basiliximab (Simulect, Novartis Pharmaceuticals Co., Basel, Switzerland) 20 mg on POD0 and 4 or antithymocyte globulin (ATG) (Thymoglobulin, Sanofi Genzyme, Cambridge, MA) 1.25 mg/kg from POD0 to 4 as induction immunosuppressants (in case of highly sensitized patients or expanded criteria deceased donor). Maintenance immunosuppression consists of tacrolimus (Tacrobell, Chong Kun Dang Pharmaceuticals Co., Seoul, Korea; Prograf, Astellas Pharma Inc., Toyama, Japan), corticosteroid, and either mycophenolate mofetil (Cellcept, Hoffmann-La Roche Inc., Nutley, NJ) or mycophenolate sodium (Myfortic, Novartis Pharmaceuticals Co.).
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6

Immunosuppressive Therapy Monitoring in Transplant Patients

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All patients received the same immunosuppressive therapy according to the clinical protocol of the IMAGEN study [4 (link)] and in line with the local standard of care. Immunosuppressive treatment consisted of tacrolimus (Prograf®, Astellas Pharma), mycophenolate mofetil (Myfenax®, Teva Pharmaceuticals), and methylprednisolone. All patients received an induction treatment of two 20-mg doses of basiliximab. From each patient, blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours after drug administration in the 1st week and at 0, 1.5, 2 and 4 hours after drug administration in the 1st, 2nd, 3rd and 6th months after transplantation. Drug analysis was performed in the respective centers involved in the study. Tacrolimus concentrations were measured in whole blood by liquid chromatography/tandem mass spectrometry, whereas MPA concentrations were determined in plasma by high-performance liquid chromatography with ultraviolet detection [15 (link)–17 (link)].
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7

Kidney Transplantation Immunosuppressive Protocol

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The data of preoperative donors and recipients were obtained from the registry system of organ donation database and then evaluated and recorded in electronic medical record system by surgeons and anesthesiologists. Anesthesia management, surgery, and perioperative care followed standard institutional protocols. A triple immunosuppressive regimen with calcineurin inhibitors (CNIs), entericcoated mycophenolate sodium (EC-MPS; Myfortic, Novartis Pharma, Basel, Switzerland) and prednisone were treated all recipients. Cyclosporine A (CsA; Sandimmun Optoral, Novartis Pharma, Nuremberg, Germany) and tacrolimus (TAC; Prograf, Astellas Pharma, Deerfield, IL, United States) composed the CNIs. The initial dosages of CsA, TAC, EC-MPS and prednisone were 4.0–4.5 and 0.06–0.08 mg/kg/day, 1,080–1,440 and 10–20 mg/day, respectively. Rabbit anti-thymocyte globulin (rATG; thymoglobulin, Genzyme Ireland, Waterford, Ireland) at a dosage of 1.25–1.50 mg/kg/day as induction therapy during the surgery were given to all recipients in a total of 4–6 days after kidney transplantation.
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8

Immunosuppressive Protocol for Transplant Patients

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The immunosuppressive protocol followed in our institution consisted of triple drug therapy consisting of tacrolimus, mycophenolate mofetil (MMF) and steroids. The induction therapy included basiliximab 20 mg (Simulect®, Novartis) on Day 0 and Day 4 after transplantation, and 500 mg intravenous (IV) methyl prednisolone (Solu Medrol®: Pfizer) pre- and 12 h postoperatively. Oral tacrolimus (Prograf®, Astellas Pharma) was started the night before transplantation 1 day with a dose of 0.1 mg/kg/day administered in two divided doses. Subsequent doses were adjusted based on clinical evaluation and whole blood levels. Mycophenolate mofetil (Cellcept®, Roche) was started with tacrolimus at a dose of 1 g twice a day and the patients’ doses were adjusted to lower doses in the presence of diarrhoea or prolonged fever. The next IV dose of steroids were decreased by half in consecutive days to 40 mg/day within one to two weeks posttransplant. Oral prednisolone (15 mg/day) was initiated right after and was tapered every week to a maintenance period of 5 mg/day.
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9

Immunosuppression prior to Ureaplasma challenge

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Mice were pharmacologically immunosuppressed using intraperitoneal (IP) mycophenolate mofetil (90 mg/kg) (Cellcept Intravenous, Roche Laboratories, Inc., Nutley, NJ), IP tacrolimus (1.2 mg/kg) (Prograf, Astellas Pharma US, Inc., Northbrook, IL), and oral prednisone (6 mg/kg) (Prednisone Intensol, Roxane Laboratories, Inc., Columbus, OH) administered daily for seven days prior to challenge with U. urealyticum and continued over six days of microbial challenge (i.e., until the day before sacrifice).
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10

Grapefruit Juice Enhances Tacrolimus Efficacy

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Patients were recruited from Kyoto University Hospital between January 2010 and March 2013. All of the patients took TAC at a single daily dose after dinner and TAC blood trough levels were measured after 12 hours (C12) by a chemiluminescent enzyme immunoassay (CLIA) (ARCHI-TECT TM i1000; Abbot, Abbot Park, USA). Seven connective tissue disease patients whose TAC (Prograf Ⓡ ; Astellas Pharma, Tokyo, Japan) blood concentration was not high enough to induce clinical improvement, even when administered 3 mg/day or more of TAC, were selected for this study. The patients consumed ~200 mL of fresh GFJ once daily because a study on patients taking the calcium-channel antagonist felodipine showed that the effectiveness of GFJ intake for an increase in felodipine blood concentration persisted for more than 24 hours (7) ; the TAC blood trough levels and clinical courses were followed thereafter. This study was conducted in accordance with the Declaration of Helsinki and its amendments and was approved by the Kyoto University Hospital Ethics Committee. All data are expressed as the mean±standard deviation (SD) values as appropriate. Student's t-test was used for the statistical analyses. p values of <0.05 were considered to indicate statistical significance.
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