A Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease
NCT ID: NCT04885647
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2021-03-12
2022-01-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm1
Low dose once every 2 weeks group
YPEG-rhEPO
YPEG-rhEPO，low dose，were subcutaneous injected once every two weeks for 13 weeks.
Arm2
Low dose once every 4 weeks group
YPEG-rhEPO
YPEG-rhEPO，low dose，were subcutaneous injected once every four weeks for 13 weeks.
Arm3
High dose once every 2 weeks group
YPEG-rhEPO
YPEG-rhEPO, high dose，were subcutaneous injected once every two weeks for 13 weeks.
Arm4
High dose once every 4 weeks group
YPEG-rhEPO
YPEG-rhEPO，high dose，were subcutaneous injected once every four weeks for 13 weeks.
Interventions
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YPEG-rhEPO
YPEG-rhEPO，low dose，were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO
YPEG-rhEPO，low dose，were subcutaneous injected once every four weeks for 13 weeks.
YPEG-rhEPO
YPEG-rhEPO, high dose，were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO
YPEG-rhEPO，high dose，were subcutaneous injected once every four weeks for 13 weeks.
Eligibility Criteria
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Inclusion Criteria
* Subjects who are diagnosed of chronic kidney disease and receiving hemodialysis (KT/V greater than or equal to 1.2). And those who had received hemodialysis, performed 2 to 3 times a week and 4 to 5 hours for every dialysis, for at least 12 weeks prior to deliver of YPEG-EPO.
* Subjects receiving rhEPO treatment, including subcutaneous and intravenous injection, for anemia due to chronic kidney disease for at least 12 weeks before randomized. And in addition, the serum hemoglobin should keep stable during the previous 12 weeks, which was defined as serum hemoglobin obtained from tests taken once a month (once a month means at least 4 weeks interval between two tests) were always kept between 100g/L and 120g/L, or else mean hemoglobin of two different tests, which were taken at least 4 weeks apart, is between 100g/L and 120g/L.
* Transferrin saturation (TSAT) greater than 20% or serum ferritin (SF) greater than 200ng/mL, serum folate greater or equal to the lower normal limit (ULN), serum vitamin B12 greater or equal to ULN，before enrollment.
* Understand and sign the informed consent form voluntarily.
Exclusion Criteria
* Subjects who are allergic to rhEPO or any of its components, or with any other evidenced allergy history that make it not suitable for participation.
* Subjects who are receiving Roxadustat Capsules at screening.
* Anemia caused by diseases or causes other than CKD, such as bleeding, hemolysis, vitamin or folate deficiency. Obvious bleeding evidence that requires blood transfusion during the lead-in period.
* Subjects suffering from pure red-cell anemia (PRCA) according to previously erythropoietin treatment.
* Subjects with serious disease or function deficiency in major organ/system, such as：
1. Medical history of myocardial infarction, cerebral stroke, vascular access thrombosis, or pulmonary embolism. Combined congestive heart failure (NYHA cardiac function equal to or grade than III). Hypertensions poorly controlled by medication (systolic blood pressure higher than 170mmHg and/or diastolic blood pressure higher than 100mmHg), or postural hypotension (systolic blood pressure below 90mmHg).
2. Medical history of malignancy, hematological disease, obvious bleeding disease, epilepsy, neuropsychiatric disease, or family history of neuropsychiatric disease.
3. Poorly controlled autoimmune diseases (including but not limit to systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, autoimmune thrombocytopenia).
4. Poorly controlled endocrine diseases, (including but not limit to thyroid disease, parathyroid disease, diabetes mellitus).
5. Co-infected with HAV, HBV, HCV, HIV, Syphilis, etc..
6. Currently suffering from severe infection or inflammation (C-reactive protein greater than 30mg / L), or currently receiving antibiotics.
* Red blood cell count greater than 6.0×10\^12/L for men while greater than 5.5×10\^12/L for female; Platelets greater than 500×10\^9/L; serum albumin lower than 30g/L; Alanine aminotransferase higher than 2 ULN, aspartame aminotransferase higher than 2ULN; Parathyroid hormone greater than 800pg/mL.
* Subjects who plan to undergo coronary artery bypass grafting (CABG), to undergo orthopedic surgery, to receive kidney transplantation, or to undergo any other major operation during the study period.
* Drug addicts or alcoholics.
* Vascular malformations (such as internal jugular vein malformation) makes it inappropriately for Hemodialysis catheterization.
* Expected survival of a certain subject is less than 12 months.
* Subjects participated in any other clinical trial within 3 months prior to screening.
* Any other situation that is not suitable for participation in this study according to the investigator's judgment.
18 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat sen University
Guanzhou, Guangdong, China
Renmin Hospital of Wuhan University/Hubei General Hospital
Wuhan, Hubei, China
The Third Xiangya Hospital Of Central South University
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First Affiliated Hospital Of Baotou Medical college,Inner Mongolia University Of Science and Technology
Hohhot, Inner Mongol, China
Huai'an Second People's Hospital/The Affiliated Huaian Hospital Of Xuzhou Medical University
Huai'an, Jiangsu, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
Xi'an Gaoxin Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital Of Chengdu Medical college
Chengdu, Sichuan, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Lishui Municipal Central Hospital
Lishui, Zhejiang, China
Countries
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Other Identifiers
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TB1901EPO
Identifier Type: -
Identifier Source: org_study_id