Prograft

Manufactured by Astellas Pharma

Sourced in Switzerland

Prograft is a laboratory equipment product manufactured by Astellas Pharma. It is designed for use in research and development applications. The core function of Prograft is to facilitate the handling and preservation of biological samples, such as cells or tissues, in a controlled and sterile environment.

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Lab products found in correlation

Simulect, by Novartis (4 mentions) Cellcept, by Roche (4 mentions) Bactrim forte, by Roche (2 mentions) Valcyte, by Roche (2 mentions) Metabolic cage, by Tecniplast (1 mentions) Rklotho, by R&D Systems (1 mentions) Balb c mice, by Orient Bio (1 mentions) Thymoglobulin, by Sanofi (1 mentions) Campath, by Sanofi (1 mentions) Tacrolimus, by Novartis (1 mentions) Certican, by Novartis (1 mentions) Everolimus, by Novartis (1 mentions)

11 protocols using prograft

Tacrolimus Pharmacokinetics in Kidney Transplant

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All patients were treated with oral twice‐daily tacrolimus (Prograft, Astellas Pharma, Leiden, The Netherlands) in combination with mycophenolic acid. Tacrolimus doses were tailored using TDM. The tacrolimus predose concentration (C₀) was measured for the first time on day 3 following transplantation in the Rotterdam cohort 33. In the Leiden cohort, blood samples were drawn before tacrolimus ingestion, and 1, 2, 3, 4, 5 and 6 h postingestion. This is routine clinical care in Leiden. In the Leiden cohort, tacrolimus concentrations for the pharmacokinetic curve were obtained at steady state, with a median of 2 weeks after transplantation. The validation cohort consisted of 304 patients, of whom seven participated in the Symphony‐Elite study. In this study, blood samples were drawn before tacrolimus ingestion, and 0.3, 0.7, 1.3, 2, 3, 4, 6, 8, 10 and 12 h postingestion 35. For the remaining 297 patients, only C₀ was available 12.
In the Rotterdam cohort, the target tacrolimus C₀ range was 10.0–15.0 ng ml^–1 in week 1–2, 8.0–12.0 ng ml^–1 in weeks 3–4, and 5.0–10.0 ng ml^–1 after week 4 post transplantation. In the Leiden cohort, the target AUC was 210 ng h ml^–1 with a corresponding C₀ range of 10.0–15.0 ng ml^–1 the first 6 weeks following transplantation. After week 6 post transplantation, the target AUC was 125 ng h ml^–1 with a corresponding C₀ range of 4.0–9.0 ng ml^–1.

Andrews L.M., Hesselink D.A., van Schaik R.H., van Gelder T., de Fijter J.W., Lloberas N., Elens L., Moes D.J, & de Winter B.C. (2019). A population pharmacokinetic model to predict the individual starting dose of tacrolimus in adult renal transplant recipients. British Journal of Clinical Pharmacology, 85(3), 601-615.

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Tacrolimus Dosage and Monitoring in Swine

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For the first month following surgery animals randomized to the tacrolimus immunomodulation group were administered 0.075 mg/kg daily (Prograft, Astellas Pharma Inc.; Northbrook IL, USA). Daily administration ranged from 3 to 4 mg during the treatment period to account for body weight; all treated and non-treated swine gained approximately the same amount of weight per week. The selected dosage is recommended for cardiac transplant surgery and has been shown to result in effective serum levels of tacrolimus of 10–20 ng/ml (Podesser et al. 2005 (link)); notably whole blood concentrations can be variable as treatment begins. Evaluation of the whole blood concentrations of tacrolimus was completed by HPLC-tandem mass spec at day 3, 9, 14, 28, and 42 post-surgery, using blood collected in EDTA anti-coagulant coated tubes. No adverse events related to tacrolimus treatment were observed.

Corona B.T., Rivera J.C., Wenke J.C, & Greising S.M. (2017). Tacrolimus as an adjunct to autologous minced muscle grafts for the repair of a volumetric muscle loss injury. Journal of Experimental Orthopaedics, 4, 36.

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Kidney Transplant Immunosuppressive Therapy

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Kidney transplant recipients received the same initial immunosuppressive therapy, except for two patients in the control group who received belatacept (Bristol-Myers Squib, NYC, NY) instead of tacrolimus. The initial immunosuppressive treatment consisted of tacrolimus (Prograft®; Astellas Pharma, Leiden, The Netherlands), mycophenolate mofetil (MMF; CellCept®; Roche Pharmaceuticals, Woerden, The Netherlands) and prednisolone treatment. All patients received induction therapy with basiliximab (Simulect®, Novartis Pharma, Arnhem, the Netherlands). The doses, whole blood or plasma target concentrations, and phasing of immunosuppressive therapy have been described elsewhere in detail [36 (link)].

Jongbloed F., de Bruin R.W., Steeg H.V., Beekhof P., Wackers P., Hesselink D.A., Hoeijmakers J.H., Dollé M.E, & IJzermans J.N. (2020). Protein and calorie restriction may improve outcomes in living kidney donors and kidney transplant recipients. Aging (Albany NY), 12(13), 12441-12467.

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Investigating Klotho's Role in Tacrolimus-Induced Kidney Injury

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Eight-week-old male BALB/c mice (Orient Bio, Seongnam-Si, Korea) were housed with a 12-h/12-h light/dark cycle, a 0.01% salt diet (Research Diets, New Brunswick, NJ, USA), and water ad libitum. After acclimation for 1 week, weight-matched mice were randomized to four groups (n=8/group) and treated together subcutaneously with 1.5 mg/(kg day) Tac (Prograft; Astellas Pharma, Ibaraki, Japan) or 10 ml/(kg day) VH (olive oil; Sigma-Aldrich, St. Louis, MO, USA), with or without recombinant mouse Klotho (rKlotho; 10 μg/kg once every 2 days, intraperitoneal injection; R&D System, Minneapolis, MN, USA) for 4 weeks. The rKlotho used was the shed, circulating form of Klotho, not the transmembrane or secreted form. Administration routes and drug doses were chosen based on previous studies.^{2 (link), 29 (link)} After the 4-week treatment, animals were housed individually in metabolic cages (Tecniplast, Buguggiate, Italy) to measure urine volumes over 24 h. Animals were then anaesthetized, and blood samples and tissue specimens were obtained for further analysis.

Lim S.W., Jin L., Luo K., Jin J., Shin Y.J., Hong S.Y, & Yang C.W. (2017). Klotho enhances FoxO3-mediated manganese superoxide dismutase expression by negatively regulating PI3K/AKT pathway during tacrolimus-induced oxidative stress. Cell Death & Disease, 8(8), e2972-.

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Post-Transplant Body Composition Evaluation

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This study is a post hoc analysis of a prospective study in which 46 adult kidney transplant recipients were included to evaluate the natural course of body composition after a kidney transplantation (not yet published). The study protocol was reviewed and approved by our medical ethical review board (MEC-2019–0723) and informed signed consent was obtained from all participants.
Patients were included in the present analysis if tacrolimus was part of their initial immunosuppressive regimen. After transplantation, patients were treated with oral twice-daily tacrolimus (Prograft®, Astellas Pharma, Leiden, The Netherlands), prednisolone, and mycophenolate mofetil.

Francke M.I., Visser W.J., Severs D., de Mik - van Egmond A.M., Hesselink D.A, & De Winter B.C. (2022). Body composition is associated with tacrolimus pharmacokinetics in kidney transplant recipients. European Journal of Clinical Pharmacology, 78(8), 1273-1287.

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Tacrolimus Dosing in Thoracic Organ Transplant

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All thoracic organ recipients admitted to the intensive care unit of the University Medical Center Utrecht between June 2013 and March 2015 were considered for inclusion. Inclusion criteria were patients aged older than 18 years who were treated with tacrolimus and provided informed consent. No patients were excluded because of the exclusion criteria: dying within 1 day after admission, known allergies for tacrolimus and macrolides, or retrieving total parenteral nutrition. The immunosuppressive regimen contained tacrolimus, Prograft^® (Astellas Pharma Europe, Leiden, The Netherlands), a cell-cycle blocker, an interleukin-2 inhibitor, and corticosteroids. Tacrolimus was dosed orally twice daily starting with 0.1 mg/kg for the lung recipients and 2 mg for the heart recipients on the day of transplantation. Dose adjustments were based on whole-blood tacrolimus concentrations at 6 a.m. (12 h after administration). The therapeutic window ranged from 9 to 15 ng/mL for all patients.

Sikma M.A., Van Maarseveen E.M., Hunault C.C., Moreno J.M., Van de Graaf E.A., Kirkels J.H., Verhaar M.C., Grutters J.C., Kesecioglu J., De Lange D.W, & Huitema A.D. (2019). Unbound Plasma, Total Plasma, and Whole-Blood Tacrolimus Pharmacokinetics Early After Thoracic Organ Transplantation. Clinical Pharmacokinetics, 59(6), 771-780.

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Basiliximab Induction and Triple Immunosuppression

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Patients received basiliximab (Simulect; Novartis Pharma, Arnhem, the Netherlands) induction therapy, followed by triple immunosuppression consisting of prednisolone, mycophenolate mofetil (Cellcept; Roche Pharmaceuticals, Woerden, the Netherlands), and tacrolimus (Prograft; Astellas Pharma, Leiden, the Netherlands). 23 The tacrolimus target predose concentrations were 7.5-12.5 ng/mL.

Francke M.I., Hesselink D.A., Andrews L.M., van Gelder T., Keizer R.J, & de Winter B.C.M. (2022). Model-Based Tacrolimus Follow-up Dosing in Adult Renal Transplant Recipients: A Simulation Trial. Therapeutic drug monitoring, 44(5).

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Kidney Transplant Immunosuppressive Strategies

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Fifty-one consecutive adult patients (≥ 18 years) who received a kidney transplant were included between March 2019 and August 2019 at the Erasmus MC, Rotterdam, the Netherlands. Written informed consent was obtained from all patients and all living donors before inclusion. All patients could be included, except for patients who also received different organ transplants (i.e. combined transplants). The study was performed in accordance with the declaration of Helsinki (2013) and was approved by the institutional review board of the Erasmus MC (Medical Ethical Review Board number 2018-035).
Donor kidneys in the study included both deceased donor organs and living donor organs (living related donors and living unrelated donors). Kidneys obtained from deceased donors were subjected to either Hypothermic Machine Perfusion (HMP), Normothermic Machine Perfusion (NMP) or Static Cold Storage (SCS).
All patients received induction therapy with either basiliximab (Simulect; Novartis Pharma, Basel, Switzerland), or rATG (Thymoglobulin, Sanofi-Genzyme), or alemtuzumab (Campath, Sanofi-Genzyme, Cambridge, MA). The maintenance immunosuppressive therapy consisted of mycophenolate mofetil (Cellcept; Roche Pharmaceuticals, Basel, Switzerland), glucocorticoids and tacrolimus (Prograft; Astellas Pharma, Leiden, the Netherlands).

Tejeda-Mora H., Verhoeven J.G., Verschoor W., Boer K., Hesselink D.A., van den Hoogen M.W., van der Laan L.J., Baan C.C., Minnee R.C, & Hoogduijn M.J. (2021). Circulating endothelial cells transiently increase in peripheral blood after kidney transplantation. Scientific Reports, 11, 8915.

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Immunosuppressive Regimen for Lung Transplant

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Induction therapy consists of basiliximab (Simulect; Novartis Pharma, Basel, Switzerland). Maintenance immunosuppression consists of a calcineurin inhibitor (CNI)-based immunosuppressive regimen (trough levels 7-10) combined with prednisolone (0.05-0.15 mg/kg) and mycophenolate mofetil (CellCept; Roche, Basel, Switzerland). tacrolimus (Prograft; Astellas Pharma, Staines, UK) is the most commonly used CNI in our center. Upon significant decline of renal function patients receive a quadruple immunosuppressive scheme adding everolimus (Certican; Novartis Pharma, Basel, Switzerland) to enable CNI dose reduction (tacrolimus trough levels 3-4; everolimus trough levels 3-4). All patients receive Pneumocystis Jerovici prophylaxis (co-trimoxazole or inhaled pentamidine) and cytomegalovirus prophylaxis (valganciclovir) if applicable. Inhaled amphotericin B is used as fungal prophylaxis in the first months and azithromycin is used as standard CLAD prophylaxis in all patients unless patients experience side-effects.

Wijbenga N., Hoek R.A.S., Mathot B.J., Seghers L., Moor C.C., Aerts J.G.J.V., Bos D., Manintveld O.C, & Hellemons M.E. (2023). Diagnostic performance of electronic nose technology in chronic lung allograft dysfunction. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 42(2).

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Multi-Transplant ATG and Tacrolimus Protocol

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Switzerland, n=5) and tacrolimus (Prograf(t)®, Astellas Pharma Europe, Staines, UK). First dose of ATG was given at day 4 (n = 21) or day 1 (n = 30) before the first implantation (9 mg/kg) and continued at 3 mg/kg for 6 days if T-lymphocyte count was above 50 /mm³. No additional ATG was administered at the second or third implantation. MMF (2g/day) or mycophenolic acid (1440 g/day) was started together with the first ATG injection and maintained at this dose, unless clinically necessary. All 5 patients who were started with mycophenolic acid were switched over to MMF within the first year after transplantation, according to availability. Patients received Tac from day 2 (n=33) or day 5 (n=18) at a dose to achieve serum trough levels of 8-10 ng/ml first 24 months and 6-8 ng/ml thereafter. Two hours before the first ATG administration and before each beta cell graft, 500 mg methylprednisolone was given intravenously.
Anti-infectious prophylaxis consisted of valganciclovir (Valcyte® 900 mg qd, Roche, Basel, Switzerland) and sulfamethoxazole/trimethoprim (Bactrim Forte® 800mg/160mg qd, Roche, Basel, Switzerland) during 100 days after each implantation.

Lee D., Keymeulen B., Hilbrands R., Ling Z., Van de Velde U., Jacobs-Tulleneers-Thevissen D., Maleux G., Lapauw B., Crenier L., De Block C., Mathieu C., Pipeleers D, & Gillard P. (2017). Age and Early Graft Function Relate With Risk-Benefit Ratio of Allogenic Islet Transplantation Under Antithymocyte Globulin-Mycophenolate Mofetil-Tacrolimus Immune Suppression. Transplantation, 101(9).

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