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

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    105
  • sponsor
    Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd
Updated on 24 February 2022

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

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 (0.8g/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)Group B (1.2g/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)Group C (1.6g/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 (8l /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 ABC 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 (1.6g/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

Details
Condition Patient of Anemia in Chronic Renal Failure With Hemodialysis
Treatment Placebo, RD01, Recombinant Human Erythropoiesis Injection (CHO cell)
Clinical Study IdentifierNCT04231292
SponsorShengzhen Sciprogen Bio-pharmaceutical Co. Ltd
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 g / L
Evaluation of dialysis adequacy during the screening period, with SpKt / V1.2 or URR65%
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
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
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
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