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

December 13, 2022 updated by: Xiamen Amoytop Biotech Co., Ltd.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China
        • Beijing Anzhen Hospital,Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China
        • The Second Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Jinan University
      • Guanzhou, Guangdong, China
        • The Third Affiliated Hospital of Sun Yat sen University
    • Hubei
      • Wuhan, Hubei, China
        • Renmin Hospital of Wuhan University/Hubei General Hospital
    • Hunan
      • Changsha, Hunan, China
        • The Third Xiangya Hospital of Central South University
      • Changsha, Hunan, China
        • Xiangya Hospital Central South University
    • Inner Mongol
      • Hohhot, Inner Mongol, China
        • The First Affiliated Hospital Of Baotou Medical college,Inner Mongolia University Of Science and Technology
    • Jiangsu
      • Huai'an, Jiangsu, China
        • Huai'an Second People's Hospital/The Affiliated Huaian Hospital Of Xuzhou Medical University
    • Liaoning
      • Dalian, Liaoning, China
        • Affiliated Zhongshan Hospital of Dalian University
    • Shanxi
      • Xi'an, Shanxi, China
        • Xi'an Gaoxin Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 361028
        • The First Affiliated Hospital of Chengdu Medical College
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin People's Hospital
      • Tianjin, Tianjin, China
        • TianJin First Central Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The first Affiliated Hospital, College of medicine, Zhejiang University
      • Lishui, Zhejiang, China
        • Lishui Municipal central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm1
Low dose once every 2 weeks group
YPEG-rhEPO,low dose,were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO,low dose,were subcutaneous injected once every four weeks for 13 weeks.
YPEG-rhEPO, high dose,were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO,high dose,were subcutaneous injected once every four weeks for 13 weeks.
EXPERIMENTAL: Arm2
Low dose once every 4 weeks group
YPEG-rhEPO,low dose,were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO,low dose,were subcutaneous injected once every four weeks for 13 weeks.
YPEG-rhEPO, high dose,were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO,high dose,were subcutaneous injected once every four weeks for 13 weeks.
EXPERIMENTAL: Arm3
High dose once every 2 weeks group
YPEG-rhEPO,low dose,were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO,low dose,were subcutaneous injected once every four weeks for 13 weeks.
YPEG-rhEPO, high dose,were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO,high dose,were subcutaneous injected once every four weeks for 13 weeks.
EXPERIMENTAL: Arm4
High dose once every 4 weeks group
YPEG-rhEPO,low dose,were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO,low dose,were subcutaneous injected once every four weeks for 13 weeks.
YPEG-rhEPO, high dose,were subcutaneous injected once every two weeks for 13 weeks.
YPEG-rhEPO,high dose,were subcutaneous injected once every four weeks for 13 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes of mean hemoglobin compared to baseline.
Time Frame: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
Time Frame: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
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.
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
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.
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.
Time Frame: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Proportion of patients with dose adjustment.
Time Frame: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
Proportion of patients requiring blood transfusion.
Time Frame: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2021

Primary Completion (ACTUAL)

January 5, 2022

Study Completion (ACTUAL)

January 5, 2022

Study Registration Dates

First Submitted

May 8, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (ACTUAL)

May 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 13, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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