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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital Of Chongqing Medical University
Changes of mean hemoglobin compared to baseline.
Time frame: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.
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.
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.
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.
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.
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.
Proportion of patients with dose adjustment.
Time frame: 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.
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YPEG-rhEPO,high dose,were subcutaneous injected once every four weeks for 13 weeks.
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
...and 7 more locations