search
Back to results

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

Primary Purpose

Renal Anemia of Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
YPEG-rhEPO
YPEG-rhEPO
YPEG-rhEPO
YPEG-rhEPO
Sponsored by
Xiamen Amoytop Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Anemia of Chronic Kidney Disease focused on measuring YPEG rhEPO, rhEPO, erythropoietin, anemia, dialysis, hemodialysis, chronic kidney disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Anzhen Hospital,Capital Medical University
  • The Second Affiliated Hospital Of Chongqing Medical University
  • The First Affiliated Hospital Of Guangzhou Medical University
  • The First Affiliated Hospital of Jinan University
  • The Third Affiliated Hospital of Sun Yat sen University
  • Renmin Hospital of Wuhan University/Hubei General Hospital
  • The Third Xiangya Hospital Of Central South University
  • Xiangya Hospital Central South University
  • The First Affiliated Hospital Of Baotou Medical college,Inner Mongolia University Of Science and Technology
  • Huai'an Second People's Hospital/The Affiliated Huaian Hospital Of Xuzhou Medical University
  • Affiliated Zhongshan Hospital of Dalian University
  • Xi'an Gaoxin Hospital
  • The First Affiliated Hospital Of Chengdu Medical college
  • Tianjin First Central Hospital
  • Tianjin People's Hospital
  • The First Affiliated Hospital, College of Medicine, Zhejiang University
  • Lishui Municipal Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm1

Arm2

Arm3

Arm4

Arm Description

Low dose once every 2 weeks group

Low dose once every 4 weeks group

High dose once every 2 weeks group

High dose once every 4 weeks group

Outcomes

Primary Outcome Measures

Changes of mean hemoglobin compared to baseline.

Secondary Outcome Measures

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).
Proportion of patients with hemoglobin fluctuations within ±10g/L compared to baseline.
Mean time of hemoglobin keeping within the target range.
Mean time from baseline to the first dose adjustment.
Changes of hemoglobin compared to baseline at the time of first dose adjustment.
Proportion of patients with dose adjustment.
Proportion of patients requiring blood transfusion.

Full Information

First Posted
May 8, 2021
Last Updated
December 13, 2022
Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
First Affiliated Hospital of Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT04885647
Brief Title
A Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
January 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Anemia of Chronic Kidney Disease
Keywords
YPEG rhEPO, rhEPO, erythropoietin, anemia, dialysis, hemodialysis, chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm1
Arm Type
Experimental
Arm Description
Low dose once every 2 weeks group
Arm Title
Arm2
Arm Type
Experimental
Arm Description
Low dose once every 4 weeks group
Arm Title
Arm3
Arm Type
Experimental
Arm Description
High dose once every 2 weeks group
Arm Title
Arm4
Arm Type
Experimental
Arm Description
High dose once every 4 weeks group
Intervention Type
Drug
Intervention Name(s)
YPEG-rhEPO
Intervention Description
YPEG-rhEPO，low dose，were subcutaneous injected once every two weeks for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
YPEG-rhEPO
Intervention Description
YPEG-rhEPO，low dose，were subcutaneous injected once every four weeks for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
YPEG-rhEPO
Intervention Description
YPEG-rhEPO, high dose，were subcutaneous injected once every two weeks for 13 weeks.
Intervention Type
Drug
Intervention Name(s)
YPEG-rhEPO
Intervention Description
YPEG-rhEPO，high dose，were subcutaneous injected once every four weeks for 13 weeks.
Primary Outcome Measure Information:
Title
Changes of mean hemoglobin compared to baseline.
Time Frame
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Secondary Outcome Measure Information:
Title
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).
Time Frame
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Title
Proportion of patients with hemoglobin fluctuations within ±10g/L compared to baseline.
Time Frame
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Title
Mean time of hemoglobin keeping within the target range.
Time Frame
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Title
Mean time from baseline to the first dose adjustment.
Time Frame
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Title
Changes of hemoglobin compared to baseline at the time of first dose adjustment.
Time Frame
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Title
Proportion of patients with dose adjustment.
Time Frame
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Title
Proportion of patients requiring blood transfusion.
Time Frame
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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： 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. 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.
Facility Information:
Facility Name
Beijing Anzhen Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Affiliated Hospital Of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The First Affiliated Hospital Of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Third Affiliated Hospital of Sun Yat sen University
City
Guanzhou
State/Province
Guangdong
Country
China
Facility Name
Renmin Hospital of Wuhan University/Hubei General Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The Third Xiangya Hospital Of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
The First Affiliated Hospital Of Baotou Medical college,Inner Mongolia University Of Science and Technology
City
Hohhot
State/Province
Inner Mongol
Country
China
Facility Name
Huai'an Second People's Hospital/The Affiliated Huaian Hospital Of Xuzhou Medical University
City
Huai'an
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
Country
China
Facility Name
Xi'an Gaoxin Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The First Affiliated Hospital Of Chengdu Medical college
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
361028
Country
China
Facility Name
Tianjin First Central Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Lishui Municipal Central Hospital
City
Lishui
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs