Zenapax

Manufactured by Roche

Sourced in United States, Switzerland

Zenapax is a laboratory equipment product. It is designed for use in research and clinical settings. The core function of Zenapax is to facilitate specific laboratory processes, but a detailed description cannot be provided while maintaining an unbiased and factual approach.

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Lab products found in correlation

Thymoglobulin, by Sanofi (3 mentions) Simulect, by Novartis (3 mentions) Neoral, by Novartis (2 mentions) Cytogam, by CSL Behring (1 mentions) Myfenax, by Teva Pharmaceuticals (1 mentions) Imuran, by GlaxoSmithKline (1 mentions) Cellcept, by Roche (1 mentions)

7 protocols using zenapax

Daclizumab Therapy in Relapsing-Remitting MS

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Participant demographics and diagnosis are presented in table 1. Twenty-three patients with RRMS received DAC-HYP 150 mg subcutaneously every 4 weeks for a minimum of 36 months; 60.9% (14/23) of these patients were treated with a previous formulation of daclizumab (Zenapax; Hoffmann-La Roche, Basel, Switzerland) for up to 6 years before enrollment in the 10-N-0125 protocol. DAC-HYP has the identical amino sequence of Zenapax, but because of expression in different cell types, its glycosylation changes affect its binding to Fc receptors.^{18 (link)} Controls (10 patients with RRMS and 4 controls with no evidence of CNS inflammation; see table e-1 at Neurology.org/nn for details) were prospectively recruited from the natural history protocol 09-N-0032 (table e-1). Diagnosis of RRMS was based on the 2010 revisions to the McDonald diagnostic criteria.^{19 (link)} The local patients (DAC-HYP: n = 17; controls: n = 14) had sample collection and analysis performed at all time points (day 0 [D0], D1, D7, and D180) whereas patients requiring long-distance travel to NIH had analysis only at D0, D1, and D180 (DAC-HYP: n = 6; controls: none).

Lin Y.C., Winokur P., Blake A., Wu T., Manischewitz J., King L.R., Romm E., Golding H, & Bielekova B. (2016). Patients with MS under daclizumab therapy mount normal immune responses to influenza vaccination. Neurology® Neuroimmunology & Neuroinflammation, 3(1), e196.

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Mechanism of Action of Daclizumab in Multiple Sclerosis

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The study was approved by the NIH Institutional Review Board and all patients provided written consent. Twenty-two RRMS patients participated in the NIH clinical trial 10-N-0125: “Investigating mechanism of action of DAC HYP in the treatment of high-inflammatory multiple sclerosis (MS)” (ClinicalTrials.gov identifier NCT01143441) and received daclizumab high yield process (Dac-HYP, 150 mg subcutaneously every 4 weeks) for a minimum of 36 months. 71% of Dac-HYP-treated patients were also treated with a previous formulation of daclizumab (Zenapax, Hoffmann-La Roche Inc.Nutley, NJ, USA) for up to 6 years prior to enrollment in the 10-N-0125 protocol. Dac-HYP has the identical amino sequence of Zenapax®, but due to expression in a different cell type and different expression system, Dac-HYP has glycosylation changes that affect its binding to Fc receptors.10 (link)
Control subjects (32 untreated RRMS patients and 11 healthy donors, [HDs]) were prospectively recruited from the natural history protocol 09-N-0032. Diagnosis of RRMS was based on the 2010 revisions to the McDonald diagnostic criteria.23 (link) All eligible control subjects studied with the modified flow cytometry immunophenotyping panel (see below) acquired between December 2012 and May 2014 were included in this study. Patients' demographic data are provided in Table1.

Lin Y.C., Winokur P., Blake A., Wu T., Romm E, & Bielekova B. (2015). Daclizumab reverses intrathecal immune cell abnormalities in multiple sclerosis. Annals of Clinical and Translational Neurology, 2(5), 445-455.

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Daclizumab Dose-Escalation in ATL Patients

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This was an NCI-IRB approved, single institution, open-label phase I/II study (clinicaltrials.gov: NCT00020020) performed at the Clinical Center of the National Cancer Institute in Bethesda, MD. All studies were approved by the IRB of the NCI, NIH and the NCI Ethics Committee and were performed in accordance with the 1964 Declaration of Helsinki and its later amendments. All persons gave their written informed consent prior to their inclusion in the study. In phase I, daclizumab (Zenapax®, Roche, Nutley, NJ) was administered to groups of ATL patients in a 3 + 3 dose-escalation design. Phase I endpoints included: (1) the determination of serious adverse events associated with saturating doses of daclizumab, the definition of the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of daclizumab in ATL, (2) determination of the dose of daclizumab required to achieve ≥95% saturation of surface CD25 on ATL cells in the peripheral blood and lymph nodes, and to maintain this saturation between treatment cycles, and (3) determination of the pharmacokinetics of high-dose daclizumab.

Berkowitz J.L., Janik J.E., Stewart D.M., Jaffe E.S., Stetler-Stevenson M., Shih J.H., Fleisher T.A., Turner M., Urquhart N.E., Wharfe G.H., Figg W.D., Peer C.J., Goldman C.K., Waldmann T.A, & Morris J.C. (2014). Safety, efficacy, and pharmacokinetics/pharmacodynamics of daclizumab (anti-CD25) in patients with adult T-cell leukemia/lymphoma. Clinical immunology (Orlando, Fla.), 155(2), 176-187.

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Induction and Immunosuppression for Kidney Transplant

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Induction therapy consisted of daclizumab (2 mg/kg intraoperatively and 1 mg/kg at 2, 4, 6, and 8 weeks, Zenapax®, Roche), antithymocyte globulin (1.5 mg/kg, 1 intraoperative and 4 daily doses, Thymoglobulin®, Genzyme), or basiliximab (20 mg intraoperatively and on post-operative day #4, Simulect, Novartis).
Triple-drug immunosuppression consisted of tacrolimus, mycophenolate mofetil, and steroids. After achieving a tacrolimus level of 8–12 ng/ml, the prednisone dose was lowered to 20 mg/day and after the first month, tapered to 5 mg/day by 3 months post-transplant. HLA-incompatible and ABO-incompatible transplant recipients also underwent peri-operative desensitization with plasmapheresis (1 volume exchange every other day) followed by administration of intravenous immunoglobulin (100mg/kg, Cytogam®, CSL Behring), as has been previously described (9 (link)).

Orandi B.J., Alachkar N., Kraus E.S., Naqvi F., Lonze B.E., Lees L., Van Arendonk K.J., Wickliffe C., Bagnasco S.M., Zachary A., Segev D.L, & Montgomery R.A. (2015). Presentation and Outcomes of C4d-Negative Antibody-Mediated Rejection After Kidney Transplantation. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 16(1), 213-220.

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Induction and Maintenance Immunosuppression Protocol

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As induction, patients received intravenous rATG (Thymoglobulin; Genzyme, Cambridge, MA) 4 mg/kg total dose from days 0 to 3 and intravenous methylprednisolone 500 mg on day 0 and 250 mg on days 1 and 2. Recipients with a history of malignancy or hematologic disorder received intravenous basiliximab (Simulect; Novartis, Basel, CH) 20 mg on days 0 and 4 or daclizumab (Zenapax; Roche, Basel, CH) 1 mg/kg on days 0, 14, 28, 42, and 56. As maintenance, patients received oral cyclosporine (Neoral; Novartis) 10 mg/kg per day and mycophenolate mofetil (Myfenax; Teva, Petach Tikva, IL) 2000 mg/d from day 0. Cyclosporine was adjusted to achieve a trough level of 200 ng/mL during the first month and 150 to 100 ng/mL thereafter. From day 3, patients received oral prednisone 20 mg/d, tapered to 5 mg/d by month 1.

Favi E., Puliatti C., Iesari S., Monaco A., Ferraresso M, & Cacciola R. (2018). Impact of Donor Age on Clinical Outcomes of Primary Single Kidney Transplantation From Maastricht Category-III Donors After Circulatory Death. Transplantation Direct, 4(10), e396.

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Kidney Transplant Immunosuppression Regimens

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Immunosuppression regimens were based on institution specific protocols which evolved during the study. Patients received induction therapy including either antithymocyte globulin (Thymoglobulin; Genzyme, Cambridge, MA, USA), alemtuzumab (Campath-1H; ILEX, San Antonio, TX, USA), interleukin 2 receptor antagonists (basiliximab) (Simulect; Novartis, Basel, Switzerland), or daclizumab (Zenapax; Roche, Basel, Switzerland) depending on their immunologic risk. Similarly, maintenance immunosuppression protocols changed throughout the study. Regimens consisted of a calcineuin inhibitor (Sandimmune; Sandoz, Holzkirchen, Germany), cyclosporine (Neoral; Novartis) or tacrolimus (Prograf; Astellas, Tokyo, Japan), plus an antiproliferative agent (azathioprine) (Imuran; GlaxoSmithKline, London, UK) or mycophenolic acid (CellCept; Roche), and low-dose corticosteroids. The current standard of care includes tacrolimus, mycophenolic acid, and prednisone.

Gonzales H.M., Taber D.J., Nadig S., Patel N., Lin A., Baliga P.K, & Rohan V.S. (2021). The impact of race on metabolic, graft, and patient outcomes after pancreas transplantation. American journal of surgery, 223(4), 812-816.

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Immunosuppression with Daclizumab, Sirolimus, and Tacrolimus

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Initial immunosuppression consisted of Daclizumab (Zenapax; Hoffman-La-Roche, Nutley, NJ) for induction, sirolimus (Rapamune; Wyeth Pharmaceuticals, Philadelphia, PA), and low dose (through 3- 6 ng/ml) of tacrolimus (Tacro) (Prograf, Astellas, Deerfield, IL) for maintenance according to the Edmonton Protocol as previously described.^{8 (link)} The target range for sirolimus through levels was 12 to 15 ng/mL for 3 months, and 7 to 10 ng/mL thereafter. Immunosuppression was modified whenever clinically necessary.

Tekin Z., Garfinkel M.R., Chon W.J., Schenck L., Golab K., Savari O., Thistlethwaite J.R., Philipson L.H., Majewski C., Pannain S., Ramachandran S., Rezania K., Hariprasad S.M., Millis J.M, & Witkowski P. (2016). Outcomes of Pancreatic Islet Allotransplantation Using the Edmonton Protocol at the University of Chicago. Transplantation Direct, 2(10), e105.

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