Cargando…

Comparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of CKD-11101, Darbepoetin Alfa (NESP(®)) Biosimilar, to Those of NESP(®) After a Single Subcutaneous or Intravenous Administration to Healthy Subjects

INTRODUCTION: Darbepoetin alfa (NESP(®) and ARANESP(®)) has a sustained erythropoietic activity with a longer half-life than conventional recombinant human erythropoietin. CKD-11101 is under clinical development as a biosimilar of darbepoetin alfa. The purpose of this study was to compare the pharma...

Descripción completa

Detalles Bibliográficos
Autores principales:	Jeon, Inseung, Oh, Jaeseong, Kwon, Yu-Kyung, Yoon, Seo Hyun, Cho, Joo-Youn, Jang, In-Jin, Yu, Kyung-Sang, Lee, SeungHwan
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Dove 2021
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8089108/ https://www.ncbi.nlm.nih.gov/pubmed/33953543 http://dx.doi.org/10.2147/DDDT.S303772

Ejemplares similares

Development and characterization of novel erythropoiesis stimulating protein (NESP)
por: Egrie, J C, et al.
Publicado: (2001)

Pharmacokinetics of novel erythropoiesis stimulating protein (NESP) in cancer patients: preliminary report
por: Heatherington, A C, et al.
Publicado: (2001)

Novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia of chronic disease associated with cancer
por: Smith, R E, et al.
Publicado: (2001)

Very small deletions within the NESP55 gene in pseudohypoparathyroidism type 1b
por: Rezwan, Faisal I, et al.
Publicado: (2015)

Antisense Activity across the Nesp Promoter is Required for Nespas-Mediated Silencing in the Imprinted Gnas Cluster
por: Tibbit, Charlotte J., et al.
Publicado: (2015)

Maternal inheritance of the Gnas cluster mutation Ex1A-T affects size, implicating NESP55 in growth
por: Eaton, Sally A., et al.
Publicado: (2013)

NESP55, a novel chromogranin-like peptide, is expressed in endocrine tumours of the pancreas and adrenal medulla but not in ileal carcinoids
por: Jakobsen, A-M, et al.
Publicado: (2003)

A dose-finding and safety study of novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia in patients receiving multicycle chemotherapy
por: Glaspy, J, et al.
Publicado: (2001)

Comparison of the Pharmacokinetic–Pharmacodynamic Relationships of Two Darbepoetin Alfa Formulations in Healthy Male Volunteers
por: Kim, Seokuee, et al.
Publicado: (2018)

Physicochemical and biological evaluation of JR-131 as a biosimilar to a long-acting erythropoiesis-stimulating agent darbepoetin alfa
por: Tani, Junya, et al.
Publicado: (2020)

Nociception Control of Bilateral Single-Shot Erector Spinae Plane Block Compared to No Block in Open Heart Surgery—A Post Hoc Analysis of the NESP Randomized Controlled Clinical Trial
por: Balan, Cosmin, et al.
Publicado: (2023)

Extended dosing of darbepoetin alfa in peritoneal dialysis patients
por: Feriani, Mariano, et al.
Publicado: (2011)

Comparable pharmacokinetics and pharmacodynamics of two epoetin alfa formulations Eporon(®) and Eprex(®) following a single subcutaneous administration in healthy male volunteers
por: Yoon, Sumin, et al.
Publicado: (2017)

Flexible dosing with Darbepoetin alfa for the treatment of chemotherapy-induced anemia
por: Wauters, Isabelle, et al.
Publicado: (2006)

Acute onset anterior uveitis after darbepoetin alfa infusion
por: Li, Jonathan, et al.
Publicado: (2015)

Switch from epoetin to darbepoetin alfa in hemodialysis: dose equivalence and hemoglobin stability
por: Arrieta, Javier, et al.
Publicado: (2014)

Iron status and erythropoiesis response to darbepoetin alfa in dogs with chronic kidney disease
por: BHAMARASUTA, Chayanont, et al.
Publicado: (2021)

JR‐131, a Biosimilar of Darbepoetin Alfa, for the Treatment of Hemodialysis Patients With Renal Anemia: A Randomized, Double‐Blinded, Parallel‐Group Phase 3 Study
por: Nishi, Shinichi, et al.
Publicado: (2019)

Long‐Term Safety and Efficacy of JR‐131, a Biosimilar of Darbepoetin Alfa, in Japanese Patients With Renal Anemia Undergoing Hemodialysis: Phase 3 Prospective Study
por: Nishi, Shinichi, et al.
Publicado: (2019)

Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial
por: Sinha, Shubhadeep D., et al.
Publicado: (2019)

Use of darbepoetin alfa in the treatment of anaemia of chronic kidney disease: clinical and pharmacoeconomic considerations
por: Carrera, Fernando, et al.
Publicado: (2009)

Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study
por: Schaefer, Franz, et al.
Publicado: (2015)

Effectiveness of darbepoetin alfa in multiple myeloma patients receiving chemotherapy including novel agents
por: Lee, Sung-Eun, et al.
Publicado: (2018)

Acquired Pure Red Cell Aplasia Following Recombinant Erythropoietin (Darbepoetin-alfa) Therapy
por: Padhi, Somanath, et al.
Publicado: (2020)

Factors affecting the doses of roxadustat vs darbepoetin alfa for anemia treatment in hemodialysis patients
por: Akizawa, Tadao, et al.
Publicado: (2020)

Correction to: Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial
por: Sinha, Shubhadeep D., et al.
Publicado: (2019)

Oral sucrosomial iron versus intravenous iron in anemic cancer patients without iron deficiency receiving darbepoetin alfa: a pilot study
por: Mafodda, Antonino, et al.
Publicado: (2017)

Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy
por: Glaspy, J A, et al.
Publicado: (2002)

Darbepoetin Versus Epoetin Alfa for the Correction of Anemia in Cancer Patients Receiving Radiotherapy or Chemoradiotherapy Treatment
por: Ots, Pilar Ma Samper, et al.
Publicado: (2008)

Baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF)
por: McMurray, John J.V., et al.
Publicado: (2013)

Intravenous and subcutaneous formulations of trastuzumab, and trastuzumab biosimilars: implications for clinical practice
por: Waller, Cornelius F., et al.
Publicado: (2021)

Darbepoetin alfa is more potent in vivo and can be administered less frequently than rHuEPO
por: Egrie, J, et al.
Publicado: (2002)

Darbepoetin alfa reduces cell death due to radiocontrast media in human renal proximal tubular cells
por: Andreucci, Michele, et al.
Publicado: (2021)

Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anaemia in patients with myelodysplastic syndromes
por: Gabrilove, Janice, et al.
Publicado: (2008)

Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study
por: Choi, Peter, et al.
Publicado: (2013)

Darbepoetin Alfa in Young Infants With Renal Failure: Single Center Experience, a Case Series and Review of the Literature
por: Libudzic-Nowak, Anna Maria, et al.
Publicado: (2018)

The Cost-Effectiveness of Using Epoetin-Beta Versus Darbepoetin-Alfa for the Treatment of Anemia Among Chronic Hemodialysis Patients
por: AlKharboush, Hanan, et al.
Publicado: (2020)

Initial responsiveness to darbepoetin alfa and its contributing factors in non-dialysis chronic kidney disease patients in Japan
por: Hayashi, Terumasa, et al.
Publicado: (2020)

Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non–Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO(2)TECT Randomized Clinical Trial of ESA-Naïve Patients
por: Winkelmayer, Wolfgang C., et al.
Publicado: (2023)

Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non–Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO(2)TECT Randomized Clinical Trial of ESA-Treated Patients
por: Parfrey, Patrick S., et al.
Publicado: (2023)

Cannot write session to /tmp/vufind_sessions/sess_lek4kqm1g1ct6ilhpon44llad7