A Phase Ⅱ Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Polyethylene Glycol Recombinant Human Erythropoietin Injection (CHO Cell) in Optimal Dose and Administration Regimen for Maintenance Therapy in Patients With Regular Dialysis Renal Anemia.

Angde Biotech Pharmaceutical Co., Ltd.1 site in 1 country150 target enrollmentApril 13, 2022

ConditionsRenal Anemia

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Renal Anemia
Sponsor: Angde Biotech Pharmaceutical Co., Ltd.
Enrollment: 150
Locations: 1
Primary Endpoint: Change of mean hemoglobin during dose adjustment period
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

This study is a multi-center, randomized, open-label, positive controlled phase II clinical study. A total of 125 to 150 patients with renal anemia receiving regular dialysis were enrolled in this study. Those patients were randomly allocated to 5 treatment groups in a ratio of 1:1:1:1:1, with 25 to 30 patients in each group.

Registry

clinicaltrials.gov

Start Date

April 13, 2022

End Date

August 16, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Angde Biotech Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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);

Outcomes

Primary Outcomes

Change of mean hemoglobin during dose adjustment period

Time Frame: Day85-Day126

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).

Change of mean hemoglobin compared to baseline during fixed treatment

Time Frame: Day1-Day42

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

Secondary Outcomes

Proportion of patients receiving red blood cell transfusion and number of transfusions during the trial.(Day1-Day126/140)
Cmax(Day1-Day126/140)
Tmax(Day1-Day126/140)
AUC 0-t(Day1-Day126/140)
Emax(Day1-Day126/140)
Reticulocyte count, Hematocrit, Erythrocyte count(Day1-Day42、Day85-Day126)
The number and proportion of patients with dose adjustments during the trial(Day1-Day126/140)
Anti-drug antibody(1,5, 9, 13, 17 weeks (before administration) and 28±2 days after the last administration (A2/B2group ,A1/B1 patients with intensive blood collection) or 14±2 days after the last administration (A1/B1 patients with sparse blood collection))
Tmax of Emax(Day1-Day126/140)
Proportion of patients with hemoglobin keeping within the target range(Day1-Day42、Day85-Day126)
Adverse events(Day1-Day126/140)
AUC 0-∞(Day1-Day126/140)
Number of iron deficiency, number of patients and proportion of patients with iron deficiency during the trial(Day1-Day126/140)
AUE0-t(Day1-Day126/140)