A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter, Non-Inferiority Study to Evaluate the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Non-Dialysis-Dependent Chronic Kidney Disease

The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with non-dialysis-dependent chronic kidney disease.

Start Date20 Jun 2019

Sponsor / Collaborator

Jiangsu Hansoh Pharmaceutical Co. Ltd.

CTR20190234 / Active, not recruitingPhase 3

培化西海马肽注射液治疗慢性肾脏病非透析患者贫血的有效性和安全性多中心随机开放阳性对照非劣效性Ⅲ期研究

[Translation] A multicenter, randomized, open-label, positively controlled, non-inferiority phase III study on the efficacy and safety of Peihuaxihaima peptide injection in the treatment of anemia in non-dialysis patients with chronic kidney disease

1) 评价培化西海马肽对比重组人促红细胞生成素（利血宝®）治疗CKD非透析患者贫血的有效性； 2) 评价培化西海马肽对比重组人促红细胞生成素（利血宝®）治疗CKD非透析患者贫血的安全性； 3) 进一步研究培化西海马肽在CKD非透析贫血患者中的量效关系。

[Translation]

1) To evaluate the effectiveness of pegylated cytokine peptide versus recombinant human erythropoietin (Lexubao®) in the treatment of anemia in non-dialysis patients with CKD; 2) To evaluate the safety of pegylated cytokine peptide versus recombinant human erythropoietin (Lexubao®) in the treatment of anemia in non-dialysis patients with CKD; 3) To further study the dose-effect relationship of pegylated cytokine peptide in non-dialysis anemic patients with CKD.

Start Date22 May 2019

Sponsor / Collaborator

Shanghai Hansoh Biomedical Co. Ltd.

[+1]

NCT03902691 / CompletedPhase 3

The purpose of this study is to evaluate the effecacy and safety of dialysis centers switching its dialysis patients from using recombinant human erythropoietin injection (CHO Cell) (ESPO) to Pegol-Sihematide injection on hemoglobin levels and other parameters.

Start Date15 May 2019

Sponsor / Collaborator

Jiangsu Hansoh Pharmaceutical Co. Ltd.

100 Clinical Results associated with Pegol-Sihematide

100 Translational Medicine associated with Pegol-Sihematide

100 Patents (Medical) associated with Pegol-Sihematide

Literatures (Medical) associated with Pegol-Sihematide

01 Nov 2023·eClinicalMedicine

Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial

Article

Author: Xu, Chengyun ; Xia, Yu'ou ; Sun, Mindan ; Chen, Qinkai ; He, Wei ; Zhong, Aimin ; Wu, Qiong ; Yan, Tiekun ; Zhang, Shiying ; Huang, Xiangyang ; Guo, Minghao ; Du, Shutong ; Yang, Aicheng ; Xu, Chunping ; Liu, Hong ; Qiu, Hongyu ; Li, Guisen ; He, Liangliang ; Jiang, Hongli ; Wang, Xiaoxia ; Pan, Chao ; Ren, Yueqin ; Zheng, Hongguang ; Zhang, Weili ; Zhang, Ping ; Yang, Xiao ; Luo, Ping ; Xie, Deqiong ; Wang, Cheng ; Chen, Menghua ; Luo, Qun ; Li, Jing ; Li, Shaomei ; Jiang, Yan ; Tang, Shuifu ; Wang, Xiaoling ; Zhou, Hua ; Lu, Guoyuan ; Sun, Bengui ; Liu, Bicheng ; Li, Chuan ; Qin, Shuguang ; Lv, Lu ; Chen, Jianghua ; Wang, Qin ; Zhou, Linghui ; Zhao, Zhanzheng

BackgroundPegmolesatide, a synthetic peptide-based erythropoietin (EPO) receptor agonist, is being evaluated as an alternative to epoetin alfa for treating anemia of chronic kidney disease (CKD) in Chinese dialysis patients. There is a critical need for a long-acting, cost-effective erythropoiesis-stimulating agent that does not produce EPO antibodies.MethodsA randomized, open-label, active-comparator, non-inferiority phase three trial was conducted at 43 dialysis centers in China between May 17th, 2019, and March 28th, 2022. Eligible patients aged 18-70 years were randomly assigned (2:1) to receive pegmolesatide once every four weeks or epoetin alfa one to three times per week, with doses adjusted to maintain a hemoglobin level between 10.0 and 12.0 g/dL. The primary efficacy endpoint was the mean change in hemoglobin level from baseline to the efficacy evaluation period in the per-protocol set (PPS) population. Non-inferiority of pegmolesatide to epoetin alfa was established if the lower limit of the two-sided 95% confidence interval for the between-group difference was ≥ -1.0 g/dL. Safety assessment included adverse events and potential anaphylaxis reactions. This trial is registered at ClinicalTrials.gov, NCT03902691.FindingsThree hundreds and seventy-two patients were randomly assigned to the pegmolesatide group (248 patients) or the epoetin alfa group (124 patients). A total of 347 patients (233 in the pegmolesatide group and 114 in the epoetin alfa group) were included in the PPS population. In the PPS, the mean change (standard deviation, SD) in hemoglobin level from baseline to the efficacy evaluation period was 0.07 (0.92) g/dL in the pegmolesatide group and -0.22 (0.97) g/dL in the epoetin alfa group. The between-group difference was 0.29 g/dL (95% confidence interval: 0.11-0.47), verifying non-inferiority of pegmolesatide to epoetin alfa. Adverse events occurred in 231 (94%) participants in the pegmolesatide group and in 110 (89%) in the epoetin alfa group. Hypertension was the most common treatment-related adverse event. No fatal cases of anaphylaxis or hypotension were reported.InterpretationMonthly subcutaneously injection of pegmolesatide was as effective and safe as conventional epoetin alfa administrated one to three times a week in treating anemia in Chinese dialysis patients.FundingThe study was supported by Hansoh Medical Development Group.

01 May 2017·European Journal of CancerQ1 · MEDICINE

Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial

Q1 · MEDICINE

Article

Author: O'Shaughnessy, Joyce ; Diéras, Véronique ; Hannah, Alison L ; Mailliez, Audrey ; Cortés, Javier ; Moreno-Aspitia, Alvaro ; Ahn, Jin-Seok ; Twelves, Chris ; Zhao, Carol ; Perez, Edith A ; Rugo, Hope S ; Schwartzberg, Lee S ; Yardley, Denise A ; Hoch, Ute ; Im, Seock-Ah ; Gómez-Pardo, Patricia ; Potter, David A ; Awada, Ahmad ; Tagliaferri, Mary

BACKGROUNDHealth-related quality of life (HRQoL) enhances understanding of treatment effects that impact clinical decision-making. Although the primary end-point was not achieved, the BEACON (BrEAst Cancer Outcomes with NKTR-102) trial established etirinotecan pegol, a long-acting topoisomerase-1 (TOP1) inhibitor, as a promising therapeutic for patients with advanced/metastatic breast cancer (MBC) achieving clinically meaningful benefits in median overall survival (OS) for patients with stable brain metastases, with liver metastases or ≥ 2 sites of metastatic disease compared to treatment of physician's choice (TPC). Reported herein are the findings from the preplanned secondary end-point of HRQoL.PATIENTS AND METHODSHRQoL, assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) (version 3.0) supplemented by the breast cancer-specific Quality of Life Questionnaire (QLQ-BR23), was evaluated post randomisation in 733 of 852 patients with either anthracycline-, taxane- and capecitabine-pretreated locally recurrent or MBC randomised to etirinotecan pegol (n = 378; 145 mg/m² every 3 weeks (q3wk)) or single-agent TPC (n = 355). Patients completed assessments at screening, every 8 weeks (q8wk) during treatment, and end-of-treatment. Changes from baseline were analysed, and the proportions of patients achieving differences (≥5 points) in HRQoL scores were compared.RESULTSDifferences were seen favouring etirinotecan pegol up to 32 weeks for global health status (GHS) and physical functioning scales (P < 0.02); numerical improvement was reported in other functional scales. The findings from HRQoL symptom scales were consistent with adverse event profiles; etirinotecan pegol was associated with worsening gastrointestinal symptoms whereas TPC was associated with worsened dyspnoea and other systemic side-effects. Analysis of GHS and physical functioning at disease progression showed a decline in HRQoL in both treatment arms, with a mean change from baseline of -9.4 and -10.8 points, respectively.CONCLUSIONThere was evidence of benefit associated with etirinotecan pegol compared with current standard of care agents in multiple HRQoL measurements, including global health status and physical functioning, despite worse gastrointestinal symptoms (e.g. diarrhoea). Patients in both arms had a decline in HRQoL at disease progression.STUDY NUMBERNCT01492101.

01 Sep 2016·Toxicology and Applied PharmacologyQ3 · MEDICINE

Chronic preclinical safety evaluation of EPO-018B, a pegylated peptidic erythropoiesis-stimulating agent in monkeys and rats

Q3 · MEDICINE

Article

Author: Chen, Yong-Chun ; Zhu, Hai ; Lu, Guo-Cai ; Xia, Zhen-Na ; Gong, Xue-Lian ; Gu, Xiao-Lei ; Li, Jian-Zhong

EPO-018B, a synthetic peptide-based erythropoiesis stimulating agent (ESA), is mainly designed for treatment of anemia caused by chronic renal failure and chemotherapy against cancer. It overcomes the deficiencies of currently approved ESA, including the frequent administration of temperature-sensitive recombinant protein and anti-EPO antibody-mediated pure red cell aplasia (PRCA). This study was designed to evaluate the potential chronic toxicity of EPO-018B. Subcutaneous administration doses were designed as 0, 0.2, 1 and 10mg/kg for six months for 160 rats (20/gender/group) and 0, 0.3, 3 and 20mg/kg for nine months for 32 monkeys (4/gender/group) once every three weeks. The vehicles received the same volume of physiological saline injection. All animals survived to the scheduled necropsies after six weeks (for rats) and fourteen weeks (for monkeys) recovery period, except for the two high-dose female rats and two high-dose male monkeys, which were considered related to the increased RBCs, chronic blood hyperviscosity and chronic cardiac injury. EPO-018B is supposed to be subcutaneously injected once every month and the intended human therapeutic dose is 0.025mg/kg. The study findings at 0.2mg/kg for rats and 0.3mg/kg for monkeys were considered to be the study NOAEL (the no observed adverse effect level), which were more than ten times the intended human therapeutic dose. Higher doses caused adverse effects related to the liver toxicity, cardiotoxicity, appearance of neutralizing antibodies of EPO-018B and the decrease of serum glucose and cholesterol. Most treatment-induced effects were reversible or revealed ongoing recovery upon the discontinuation of treatment. The sequelae occurred in rats and monkeys were considered secondary to exaggerated pharmacology and would less likely occur in the intended patient population. As to the differences between human beings and animals, the safety of EPO-018B need to be further confirmed in the future clinical studies.

News (Medical) associated with Pegol-Sihematide

05 Jan 2021

·www.globenewswire.com

Chronic Kidney Disease (CKD) Pipeline Insight, 2020 Report Featuring 55 Key players & 10 Key Products

Dublin, Dec. 31, 2020 (GLOBE NEWSWIRE) -- The "Chronic Kidney Disease (CKD) - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering. The "Chronic Kidney Disease (CKD) - Pipeline Insight, 2020," report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Chronic Kidney Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Chronic Kidney Disease Emerging Drugs Chapters This segment of the Chronic Kidney Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Chronic Kidney Disease Emerging Drugs AZD5718: AstraZeneca AstraZeneca is conducting a study to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease. The study will be conducted in approximately 118 study centers across 12 countries. The overall study period will be around 28 weeks. Approximately 632 participants comprising of 67% diabetic kidney disease (DKD) and 33% non-DKD participants will be enrolled. DDO-3055: Jiangsu HengRui Medicine Co., Ltd. Jiangsu HengRui Medicine is conducting a randomized, double-blind, dose-escalating, placebo controlled, phase I study to evaluate the safety and pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with Chronic Kidney Disease. This is a randomized, double-blind, dose-escalating, placebo controlled, Phase I study to evaluate the safety, pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with chronic kidney disease. 48 healthy volunteers will be enrolled in Part A, and 18 patients with chronic kidney disease will be enrolled in Part B. Chronic Kidney Disease: Therapeutic Assessment This segment of the report provides insights about the different Chronic Kidney Disease drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Chronic Kidney Disease There are approx. 50+ key companies which are developing the therapies for Chronic Kidney Disease. The companies which have their Chronic Kidney Disease drug candidates in the mid to advanced stage, i.e. phase III and Phase II include, AstraZeneca, UnicoCell Biomed, Jiangsu Hansoh Pharmaceutical, Bio Sidus, Keryx Biopharmaceuticals, AMAG Pharmaceuticals, inRegen, AbbVie etc. Phases The report covers around 50+ products under different phases of clinical development like Mid-stage products (Phase II and Phase I/II) Early-stage products (Phase I/II and Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Chronic Kidney Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Subcutaneous Intravenous Oral Intramuscular Molecule Type Products have been categorized under various Molecule types such as Small molecules Proteins and peptides Polymers Diamines Chlorinated hydrocarbons Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Chronic Kidney Disease: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic Kidney Disease therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chronic Kidney Disease drugs. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Kidney Disease R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Kidney Disease. August 2020: DAPA-CKD trial meets primary endpoint in patients with chronic kidney disease. Dapagliflozin reduces the risk of kidney failure, death from cardiovascular causes or heart failure hospitalisation and all-cause mortality in chronic kidney disease patients with or without type 2 diabetes. That's the main result of the DAPA-CKD trial presented in a Hot Line session today at ESC Congress 2020. Chronic Kidney Disease Report Insights Chronic Kidney Disease Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Chronic Kidney Disease Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing Chronic Kidney Disease drugs? How many Chronic Kidney Disease drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Kidney Disease? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chronic Kidney Disease therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Chronic Kidney Disease and their status? What are the key designations that have been granted to the emerging drugs? Key Players AdAlta Ltd Allena Pharmaceuticals Inc apceth Biopharma GmbH Arch Biopartners Inc Astellas Pharma Inc AstraZeneca Plc Bayer AG BiOrion Technologies BV Boehringer Ingelheim GmbH Boryung Pharmaceutical Co Ltd Celgene Corp Certa Therapeutics Pty Ltd Conatus Pharmaceuticals Inc Corvidia Therapeutics Inc DiaMedica Therapeutics Inc Dimerix Bioscience Pty Ltd DiscoveryBiomed Inc DURECT Corp Epigen Biosciences Inc Galectin Therapeutics Inc GenKyoTex SA GNI Group Ltd iBio Inc IC-MedTech Inc Ipsen SA Isarna Therapeutics GmbH KBP BioSciences Co Ltd Kidney Fibrosis Klotho Therapeutics Inc Les Laboratoires Servier SAS ManRos Therapeutics Mironid Ltd NovaTarg Therapeutics Inc Novo Nordisk AS OPKO Health Inc Opsidio LLC Otsuka Holdings Co Ltd Pharmaxis Ltd Q BioMed Inc Redx Pharma Plc Regulus Therapeutics Inc Resverlogix Corp Sanwa Kagaku Kenkyusho Co Ltd Sarfez Pharmaceuticals Inc Scholar Rock Inc Sirnaomics Inc Sphaera Pharma Pte Ltd Symic Biomedical Inc Taisho Pharmaceutical Holdings Co Ltd Theravance Biopharma Inc Unity Biotechnology Inc Vascular Biogenics Ltd Vascular BioSciences VESSL Therapeutics Ltd Vicore Pharma AB Key Products AZD5718 MEDI8367 efepoetin alfa Verinurad Empagliflozin DDO-3055 KBP-5074 Doxercalciferol TRC101 Pegol-Sihematide For more information about this drug pipelines report visit Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research. CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

Small molecular drugAcquisitionCollaborate

100 Deals associated with Pegol-Sihematide

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia in chronic kidney disease	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	30 Jun 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anemia of renal disease	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	15 May 2019
myelodysplastic anemia	Phase 1	CN	Jiangsu Hansoh Pharmaceutical Co. Ltd.	20 Jun 2014

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03902691 (Literature) Manual	Phase 3	chronic renal failure anemia	372	pegmolesatide	(eukpbdhzbi) = sibcfwoloz uhrvraugat (corxzwrzej, 0.92) View more	Non-inferior	28 Oct 2023
NCT03902691 (Literature) Manual	Phase 3	chronic renal failure anemia	372	epoetin alfa	(eukpbdhzbi) = zsobtydlbk uhrvraugat (corxzwrzej, 0.97) View more	Non-inferior	28 Oct 2023
ISN WCN2022	Not Applicable	Anemia in chronic kidney disease	372	Pegmolesatide	rcejramrub(vrqgnxyvux) = 1.6% who received Pegmolesatide and 3.2% who received the Epoetin alfa prkowsnxgi (cgmmithuaw ) View more	Positive	01 Feb 2022

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