A Phase 2 Clinical Study of Pegerythropoietin Injection (RD01) for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis

NCT ID: NCT04231292

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-12-31

Brief Summary

A multicenter randomized, single blind, active comparator controlled phase 2 study which is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis

Detailed Description

This trial is a multicenter randomized, single blind, active comparator controlled phase 2 study. The study is divided into two stages. The first stage lasts for 18 weeks, and is divided into fixed dose period (day 1~ 6th week ) and dose adjustment period (7th ~ 18th week). The second stage lasts for 28 weeks, and is also divided into dose adjustment period (19th ~ 38th week) and evaluation period (39th ~ 46th week).

Patients are randomly assigned to seven study groups in the first stage. Of all these seven groups, six groups are: Group A (0.8μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、Group B (1.2μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、Group C (1.6μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、 Group D (0.8ug/kg RD01, once every two weeks, intravenous injection, for 18 weeks)、Group E ( 150 IU/kg rHuEPO, once a week, subcutaneous injection, for 18 weeks )、Group F (8μl /kg placebo, once every two weeks, for 6 weeks; then 150 IU/kg rHuEPO, once a week, subcutaneous injection, 7th ~ 18th week ).

At the beginning of the second stage, some patients in these six goups need to be be randomized again. Of which patients in Group A、B、C are randomly assigned to Group a ( RD01, once every two weeks, subcutaneous injection, 19th ~ 46th week )、Group b (RD01, once every four weeks, subcutaneous injection, 19th ~ 46th week)、Group c (RD01, once every six weeks, subcutaneous injection, 19th ~ 46th week); Patients in Group D enter directly to Group d (RD01, once every four weeks, intravenous injection, 19th ~ 46th week); Patients in Group E and F are randomly assigned to Group e (rHuEPO once a week, intravenous injection, 19th ~ 46th week ) and Group f (rHuEPO once a week, subcutaneous injection, 19th ~ 46th week). The starting dose of the second stage for individual patient in all groups refers to the weekly dose at the end of the first stage .

During the whole study period, all patients in six groups are not allowed to adjust dosage in the first 6 weeks, while in the remaining trial period dosage adjustment was allowed once every two weeks if necessary.

There is a special Group G (1.6μg/kg RD01, once every four weeks, subcutaneous injection, Day 1 ~ 28th week), all patients are allowed to adjust dosage during the whole 28 weeks.

This phase 2 study is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis

Conditions

Patient of Anemia in Chronic Renal Failure With Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group A +Group a

Group A: 0.8μg/kg RD01, once every two weeks, Day 1\~ 18th week;Group a: refers to the weekly dose at the end of the first stage , once every two weeks, 19th\~46th week

Group Type: EXPERIMENTAL

RD01

Intervention Type: DRUG

RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin

Experimental Group B +Group b

Group B: 1.2μg/kg RD01, once every two weeks, Day 1\~ 18th week; Group b: refers to the weekly dose at the end of the first stage , once every four weeks, 19th\~46th week

Group Type: EXPERIMENTAL

RD01

Intervention Type: DRUG

RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin

Experimental Group C +Group c

Group C: 1.6μg/kg RD01, once every two weeks, Day 1\~ 18th week; Group c: refers to the weekly dose at the end of the first stage , once every six weeks, 19th\~46th week

Group Type: EXPERIMENTAL

RD01

Intervention Type: DRUG

RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin

Experimental Group D +Group d

Group D: 0.8μg/kg RD01, once every two weeks, Day 1\~ 18th week; Group d: refers to the weekly dose at the end of the first stage , once every four weeks, 19th\~46th week

Group Type: EXPERIMENTAL

RD01

Intervention Type: DRUG

RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin

Experimental Group E +Group e

Group E: 150IU/kg rHuEPO, once a weeks, subcutaneous administration, Day 1\~ 18th week; Group e: refers to the weekly dose at the end of the first stage , once a weeks, intravenous administration, 19th\~46th week

Group Type: ACTIVE_COMPARATOR

Recombinant Human Erythropoiesis Injection (CHO cell)

Intervention Type: DRUG

rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin

Experimental Group F +Group f

Group F: 8μl placebo, once every two weeks, for 6 weeks; 150 IU/kg rHuEPO, once week, subcutaneous injection, 7th \~ 18th week; Group f: refers to the weekly dose at the end of the first stage , once a weeks, subcutaneous administration, 19th\~46th week

Group Type: PLACEBO_COMPARATOR

Recombinant Human Erythropoiesis Injection (CHO cell)

Intervention Type: DRUG

rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin

placebo

Intervention Type: DRUG

placebo

Experimental Group G

Group G: 1.6μg/kg RD01, once every four weeks, Day 1\~ 28th week;

Group Type: EXPERIMENTAL

RD01

Intervention Type: DRUG

RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin

Interventions

RD01

RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin

Intervention Type: DRUG

Recombinant Human Erythropoiesis Injection (CHO cell)

rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

pegerythropoietin Injection; rHuEPO

Eligibility Criteria

Inclusion Criteria

• Patients with chronic renal failure who are undergoing maintenance hemodialysis for at least 12 weeks;
• 18 ≤ age ≤ 75 years of age, male or female;
• Patients who have received short-acting EPO treatment and meets the treatment standard (hemoglobin 100 ~ 120 g / L). The mean Hb value in the screening period (at least two weeks apart ) is within the range of 100 ~ 120 g / L (both ends). The difference is less than 10g / L;
• Evaluation of iron status during the screening period, transferrin saturation (TSAT) ≥20% or serum ferritin (SF) ≥200 μg / L;
• Evaluation of dialysis adequacy during the screening period, with SpKt / V≥1.2 or URR≥65%;
• Subjects agree to use reliable contraceptives from the screening period to within 6 months after the last medication
• Sign the informed consent.

Exclusion Criteria

• Patients who have received or plan to have a kidney transplant during the study period
• Except of renal anemia, there are other diseases that cause chronic anemia (such as sickle cell anemia, myelodysplastic syndrome, hematological malignancies, myeloma, hemolytic anemia, pure red blood cell aplastic anemia)
• Patients with acute or chronic blood loss (such as upper gastrointestinal bleeding) in the past 3 months or patients who have undergone surgery with extensive bleeding, or patients who plan to undergo surgery during the study period
• Patients with coagulation dysfunction (time to activate partial thromboplastin> 1.5 times the upper limit of normal value)
• The following circumstances (including but not limited to) during the screening, investigators evaluated that it is not suitable for enrollment:

1. Abnormal liver function (aspartate aminotransferase or alanine aminotransferase is more than 3 times the upper limit of normal value);

2. Patients who were positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antigen (HBeAg), HIV antibody (HIV-Ab), hepatitis C virus antibody (HCV-Ab) or Treponema pallidum antibody;

• Patients with severe secondary hyperparathyroidism (iPTH> 1000 ng / L);
• Patients with severe hypertension and poor control of blood pressure (systolic blood pressure> 180 mmHg or diastolic blood pressure> 100 mmHg)
• Patients with severe thromboembolic disease
• People with severe cardio-cerebral vascular disease (excluding luminal infarction), severe or unstable coronary artery disease, heart failure (NYHA III or IV) or myocardial infarction or stroke within 3 months
• Patients with malignant tumors (excluding non-melanoma skin cancer or resected cancer in situ)
• People with a history of severe allergies (including drug allergies), allergies to erythropoietin, or allergic to any component of the test drug (such as human serum albumin)
• People with severe infection who are receiving systemic antibiotics
• Patients who have received androgen therapy or blood transfusion therapy within the last 8 weeks;
• Participated in other new drug clinical trials as a subject within 3 months or the withdrawal time was shorter than the 5 half-life of the test drug at the time of enrollment (whichever is the longest);
• Patients with a history of seizures
• Pregnant and lactating women
• Alcohol, drug or drug addicts
• Other situations that the researcher believes may affect validity judgment or are not suitable for participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renal Rheumatology and Immunology department Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gengru Jiang, Medical PhD

Role: CONTACT

jianggeng-ru@hotmail.com

13816238339

Other Identifiers

SZSBE-RD01-HD-II-01

Identifier Type: -

Identifier Source: org_study_id