A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia .

NCT05629598 | Unknown Phase 2

• 1 other identifier: CRAD-006-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.

Conditions

Renal Anemia

Keywords

PEG-EPO

Outcome Measures

Primary Outcomes (2)

• Change of mean hemoglobin compared to baseline during fixed treatment

  Change of mean hemoglobin (Hb) content from baseline during fixed treatment (fixed treatment：week 1 to week 6)

  Day1-Day42

• Change of mean hemoglobin during dose adjustment period

  Change of mean hemoglobin compared to baseline from week 13 to 18 during dose adjustment period (dose adjustment period: week 7 to week 18/week 20).

  Day85-Day126

Secondary Outcomes (14)

• Proportion of patients with hemoglobin keeping within the target range

  Day1-Day42、Day85-Day126

• Reticulocyte count, Hematocrit, Erythrocyte count

  Day1-Day42、Day85-Day126

• Proportion of patients receiving red blood cell transfusion and number of transfusions during the trial.

  Day1-Day126/140

• Number of iron deficiency, number of patients and proportion of patients with iron deficiency during the trial

  Day1-Day126/140

• The number and proportion of patients with dose adjustments during the trial

  Day1-Day126/140

Study Arms (5)

A1

EXPERIMENTAL

Recombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)\* 0.004 (conversion coefficient), Q2W for administration.

Biological: Recombinant human erythropoietin injection

B1

EXPERIMENTAL

Recombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)\* 0.008 (conversion coefficient), Q2W for administration.

Biological: Recombinant human erythropoietin injection

A2

EXPERIMENTAL

Recombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)\* 0.004 (conversion coefficient), Q4W for administration.

Biological: Recombinant human erythropoietin injection

B2

EXPERIMENTAL

Recombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)\* 0.008 (conversion coefficient), Q4W for administration.

Biological: Recombinant human erythropoietin injection

C

ACTIVE COMPARATOR

Human erythropoietin injection；Refer to the product instructions.

Biological: Human erythropoietin injection

Interventions

Recombinant human erythropoietin injection BIOLOGICAL

The dose of PEG-EPO (CHO cells) is converted according to the average weekly dose of short-acting EPO before randomization (4 weeks before randomization) multiplied by the corresponding conversion coefficient (low conversion coefficient is 0.004, High conversion coefficient is 0.008).

A1; A2; B1; B2

Human erythropoietin injection BIOLOGICAL

Refer to the product instructions

C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients at the age of 18\~75 (including critical value).
• Patients clinically diagnosed with renal anemia who have received dialysis for at least 12 weeks (hemodialysis≥3 times/week, total urea clearance index (Kt/V) ≥1.2 or urea reduction rate (URR) ≥65%; peritoneal dialysis≥4 times/day, weekly Kt/V≥1.7);
• Hb in screening period should be within the range of 100\~130g/L (including both ends), and the deviation should not exceed 10g/L;
• Iron status (TSAT ≥20% or SF ferritin ≥100μg/L) during screening.
• Have been stably treated with short-acting EPO 1-3 times per week for at least 12 weeks before baseline;
• Consent to use reliable contraceptive methods and no family planning from the screening period to 3 months after the last administration；
• Voluntarily participate in the trial and sign the informed consent form.

You may not qualify if:

• Patients with a history of severe allergies (including drug allergies), especially allergic to erythropoietin, or to any component of the test drug (e.g. polyethylene glycol);
• Have a history of kidney transplantation or plan to undergo kidney transplantation during the trial；
• Have any other disease that causes chronic anemia (e.g., sickle cell anemia, myelodysplastic syndrome, hematologic malignancy, myeloma, hemolytic anemia, pure red cell aplastic anemia) or PRCA following therapy of erythropoietin protein;
• Suffered from acute or chronic blood loss (such as gastrointestinal bleeding) or undergwent surgical procedures due to massive bleeding within 3 months before screening, or plan to have a surgery during the clinical trial (except for arteriovenous fistula or peritoneal dialysis tube adjustment);
• Have a history of malignant tumors within the past 5 years (excluding non-melanoma skin cancer or excised carcinoma in situ);
• Suffer from autoimmune diseases (such as rheumatoid arthritis or systemic lupus erythematosus) or diseases of endocrine system (such as poorly controlled diabetes mellitus complicated with peripheral vascular diseases, severe secondary hyperparathyroidism \[parathyroid hormone \> 800ng/L\]);
• Received systemic antibiotic treatment or C-reactive protein ≥30mg/L within 4 weeks due to severe infection before screening;
• The following conditions occur during screening period:
• Hepatic dysfunction (AST or ALT\>3 times ULN); Coagulation dysfunction (activated partial thrombin time \> 1.5 times ULN); Folic acid or vitamin B12 deficiency (serum folic acid level \<LLN, vitamin B12 \<LLN); Positive for HBsAg, HBcAb, HIV-ABb, HCV-AbB or TP-Ab;
• Suffer from severe thromboembolic disease, poorly controlled severe hypertension (SBP before dialysis \> 170mmHg or DBP ≥100mmHg) or hypotension (SBP before dialysis \<90mmHg);
• Suffer from severe cardiovascular and cerebrovascular disease, severe or unstable coronary artery disease, heart failure (NYHA CLASS III or IV), or those who received coronary artery bypass grafting or percutaneous coronary intervention within 6 months, or those who had a history of myocardial infarction or stroke within 3 months;
• Received androgen therapy or blood transfusion within 8 weeks before screening period;
• Received long-acting ESAs within 3 months or HIF-PHI (e.g., rosalat) within 2 weeks before initial administration;
• Participated in other clinical trials as a subject within 4 weeks before screening period or the duration from the last administration to enrollment was shorter than the 5 half-lives of the drug;
• Have a history of epileptic seizures or mental illness;

Sponsors & Collaborators

• Angde Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospitial,College of Medicine,Zhejiang University

Hanzhou, Zhejiang, 310003, China

RECRUITING

Central Study Contacts

Jianghua Chen, Master

CONTACT

0571-87236996; zyct79@163.com

Xiaoying Du, Master

CONTACT

0571-87236996; zyct79@163.com

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: June 27, 2022
• First Posted: November 29, 2022
• Study Start: April 13, 2022
• Primary Completion: March 17, 2023
• Study Completion: August 16, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (1)