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

NCT04885647 | Completed Phase 2

• 1 other identifier: TB1901EPO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Renal Anemia of Chronic Kidney Disease

Keywords

YPEG rhEPO; rhEPO; erythropoietin; anemia; dialysis; hemodialysis; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Changes of mean hemoglobin compared to baseline.

  14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

Secondary Outcomes (7)

• 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.

• 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.

• Mean time of hemoglobin keeping within the target range.

  14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

• Mean time from baseline to the first dose adjustment.

  14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

• 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.

Study Arms (4)

Arm1

EXPERIMENTAL

Low dose once every 2 weeks group

Drug: YPEG-rhEPO

Arm2

EXPERIMENTAL

Low dose once every 4 weeks group

Drug: YPEG-rhEPO

Arm3

EXPERIMENTAL

High dose once every 2 weeks group

Drug: YPEG-rhEPO

Arm4

EXPERIMENTAL

High dose once every 4 weeks group

Drug: YPEG-rhEPO

Interventions

YPEG-rhEPO DRUG

YPEG-rhEPO，low dose，were subcutaneous injected once every two weeks for 13 weeks.

Arm1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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：
• 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).
• Medical history of malignancy, hematological disease, obvious bleeding disease, epilepsy, neuropsychiatric disease, or family history of neuropsychiatric disease.
• Poorly controlled autoimmune diseases (including but not limit to systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, autoimmune thrombocytopenia).
• Poorly controlled endocrine diseases, (including but not limit to thyroid disease, parathyroid disease, diabetes mellitus).
• Co-infected with HAV, HBV, HCV, HIV, Syphilis, etc..
• 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.

Sponsors & Collaborators

• Xiamen Amoytop Biotech Co., Ltd.: lead
• First Affiliated Hospital of Zhejiang University: collaborator

Study Sites (17)

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Location

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

The Third Affiliated Hospital of Sun Yat sen University

Guanzhou, Guangdong, China

Location

Renmin Hospital of Wuhan University/Hubei General Hospital

Wuhan, Hubei, China

Location

The Third Xiangya Hospital Of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital Of Baotou Medical college,Inner Mongolia University Of Science and Technology

Hohhot, Inner Mongol, China

Location

Huai'an Second People's Hospital/The Affiliated Huaian Hospital Of Xuzhou Medical University

Huai'an, Jiangsu, China

Location

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Location

Xi'an Gaoxin Hospital

Xi’an, Shanxi, China

Location

The First Affiliated Hospital Of Chengdu Medical college

Chengdu, Sichuan, 361028, China

Location

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Lishui Municipal Central Hospital

Lishui, Zhejiang, China

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 13, 2021
• Study Start: March 12, 2021
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)