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

NCT04231292 | Unknown Phase 2

• 1 other identifier: SZSBE-RD01-HD-II-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

Patient of Anemia in Chronic Renal Failure With Hemodialysis

Outcome Measures

Primary Outcomes (4)

• Primary efficacy index : The change of hemoglobin concentration of experimental group from baseline to the end of 4th and 6th week

  Day 1~4th week & Day 1~6th week

• Primary efficacy index: The difference of hemoglobin concentration between the experimental group and the placebo group at the end of 4th and 6th week;

  Day 1~4th week & Day 1~6th week

• Primary efficacy index: hemoglobin concentration change from baseline to the end of first stage

  The amount of change in hemoglobin concentration from baseline to the end of the first stage

  Day 1~18th week

• Primary efficacy index: hemoglobin concentration change from baseline to the evaluation periods in the second stage (39th ~46th week)

  The amount of change in hemoglobin concentration from baseline to the evaluation periods in the second stage (39th \~46th week).

  Day 1~ evaluation periods (39th ~46th week)

Secondary Outcomes (9)

• Secondary efficacy index: the optimal dosage

  the end of 18th week & 39th ~46th week

• Secondary efficacy index: maintenance rate

  39th-46th week

• Secondary efficacy index : Proportion of subjects with unstable Hb during the evaluation period

  39th-46th week

• Secondary efficacy index: proportion of times of Hb remains within the target range

  39th-46th week

• Secondary efficacy index: EPO dose conversion coefficient of RD01

  end of 18th week & 39th ~46th week

Study Arms (7)

Experimental Group A +Group a

EXPERIMENTAL

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

Drug: RD01

Experimental Group B +Group b

EXPERIMENTAL

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

Drug: RD01

Experimental Group C +Group c

EXPERIMENTAL

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

Drug: RD01

Experimental Group D +Group d

EXPERIMENTAL

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

Drug: RD01

Experimental Group E +Group e

ACTIVE COMPARATOR

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

Drug: Recombinant Human Erythropoiesis Injection (CHO cell)

Experimental Group F +Group f

PLACEBO COMPARATOR

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

Drug: Recombinant Human Erythropoiesis Injection (CHO cell); Drug: placebo

Experimental Group G

EXPERIMENTAL

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

Drug: RD01

Interventions

RD01 DRUG

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

Also known as: pegerythropoietin Injection

Experimental Group A +Group a; Experimental Group B +Group b; Experimental Group C +Group c; Experimental Group D +Group d; Experimental Group G

Recombinant Human Erythropoiesis Injection (CHO cell) DRUG

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

Also known as: rHuEPO

Experimental Group E +Group e; Experimental Group F +Group f

placebo DRUG

placebo

Experimental Group F +Group f

Eligibility Criteria

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

You may qualify if:

• Patients with chronic renal failure who are undergoing maintenance hemodialysis for at least 12 weeks;
• ≤ 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Central Study Contacts

Gengru Jiang, Medical PhD

CONTACT

13816238339; jianggeng-ru@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: March 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2022
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

CN (1)