A Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease

Renal Anemia of Chronic Kidney Disease Clinical Trial

Official title:

A Multicenter, Randomized, Open-label, Phase 2 Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease, Who Has Previously Treated With rhEPO and Maintains the Hemoglobin in a Stabilize State

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885647
• Other study ID #: TB1901EPO
• Status: Completed
• Phase: Phase 2
• Start date: March 12, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: December 2022
• Source: Xiamen Amoytop Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of YPEG rhEPO, a recombinant human erythropoietin pegylated by Y shape polyethylene glycol, in patients with anemia due to Chronic Kidney Disease (CKD), assessed by hemoglobin maintenance, adverse events and health-related quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 5, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 70 years old, including 18 and 70 years.

• 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:

• Women of pregnancy, lactating, or planning to pregnant, or patients who are planning to donate sperms/eggs during the study period.

• 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.

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Anemia of Chronic Kidney Disease
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital,Capital Medical University	Beijing	Beijing
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 Chengdu Medical college	Chengdu	Sichuan
China	The Second Affiliated Hospital Of Chongqing Medical University	Chongqing	Chongqing
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
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	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang
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	Lishui Municipal Central Hospital	Lishui	Zhejiang
China	Tianjin First Central Hospital	Tianjin	Tianjin
China	Tianjin People's Hospital	Tianjin	Tianjin
China	Renmin Hospital of Wuhan University/Hubei General Hospital	Wuhan	Hubei
China	Xi'an Gaoxin Hospital	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xiamen Amoytop Biotech Co., Ltd.	First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of mean hemoglobin compared to baseline.		14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Secondary	Proportion of patients with hemoglobin keeping within the target range (the target hemoglobin range is defined as hemoglobin keeping between 100g/L and 120g/L).		14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Secondary	Proportion of patients with hemoglobin fluctuations within ±10g/L compared to baseline.		14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Secondary	Mean time of hemoglobin keeping within the target range.		14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Secondary	Mean time from baseline to the first dose adjustment.		14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Secondary	Changes of hemoglobin compared to baseline at the time of first dose adjustment.		14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Secondary	Proportion of patients with dose adjustment.		14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Secondary	Proportion of patients requiring blood transfusion.		14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.