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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | Low dose once every 2 weeks group |
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| Arm2 | Experimental | Low dose once every 4 weeks group |
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| Arm3 | Experimental | High dose once every 2 weeks group |
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| Arm4 | Experimental | High dose once every 4 weeks group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YPEG-rhEPO | Drug | YPEG-rhEPO,low dose,were subcutaneous injected once every two weeks for 13 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of mean hemoglobin compared to baseline. | 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups. |
| Measure | Description | 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). | 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. |
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Inclusion Criteria:
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital,Capital Medical University | Beijing | Beijing Municipality | China | |||
| The Second Affiliated Hospital Of Chongqing Medical University |
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| YPEG-rhEPO |
| Drug |
YPEG-rhEPO,low dose,were subcutaneous injected once every four weeks for 13 weeks. |
|
| YPEG-rhEPO | Drug | YPEG-rhEPO, high dose,were subcutaneous injected once every two weeks for 13 weeks. |
|
| YPEG-rhEPO | Drug | YPEG-rhEPO,high dose,were subcutaneous injected once every four weeks for 13 weeks. |
|
| 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. |
| Proportion of patients with dose adjustment. | 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups. |
| Proportion of patients requiring blood transfusion. | 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups. |
| 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 |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Liaoning | China |
| Xi'an Gaoxin Hospital | Xi’an | Shanxi | China |
| The First Affiliated Hospital Of Chengdu Medical college | Chengdu | Sichuan | 361028 | China |
| Tianjin First Central Hospital | Tianjin | Tianjin Municipality | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| Lishui Municipal Central Hospital | Lishui | Zhejiang | China |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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