Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With NDD-CKD

NCT03903809 | Unknown Phase 3 DMC

• 1 other identifier: HS-20039-301
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with non-dialysis-dependent chronic kidney disease.

Conditions

Non-Dialysis-Dependent Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• The mean change from the baseline hemoglobin level to the mean level during the evaluation period

  The primary efficacy end point is the mean change from the baseline hemoglobin level to the mean level during the evaluation period. The baseline hemoglobin value is the value on the day of randomization. The mean hemoglobin during the evaluation period was calculated as the mean of all available hemoglobin values during that period. Hemoglobin measurements will be performed at baseline and thereafter every 2 weeks (for the dose adjustment and the evaluation periods). Efficacy will be also assessed as the mean change from baseline in hemoglobin levels during 4-week intervals.

  Week 17-24

Secondary Outcomes (5)

• The mean change from the baseline hemoglobin level to the mean level at each visit

  Week 0-52

• The proportion of patients with hemoglobin within the target range of 10.0 to 12.0 g/dL during the evaluation period

  Week 17-24

• The mean dose of patients with Pegol-Sihematide achieving a target hemoglobin range during the evaluation period

  Week 17-24

• First time for patients achieving a response to hemoglobin during any treatment periods

  Week 0-52

• First time for patients achieving a target hemoglobin range during any trial periods

  Week 0-52

Other Outcomes (3)

• The SAE of Pegol-Sihematide

  Week 0-52

• The incidence of patients with risk cardiovascular events of Pegol-Sihematide

  Week 0-52

• The antibody of Pegol-Sihematide

  Week 0-52

Study Arms (2)

HS-20039 Pegol-Sihematide

EXPERIMENTAL

Pegol-Sihematide's starting dose of 0.025 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 13 doses

Drug: Pegol-Sihematide

ReHuman Erythropoietin Injection

ACTIVE COMPARATOR

ESPO(Recombinant Human Erythropoietin Injection) ESPO's starting dose was 6000 IU per week

Drug: ESPO

Interventions

Pegol-Sihematide DRUG

Participants received Pegol-Sihematide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).

Also known as: HS-20039

HS-20039 Pegol-Sihematide

ESPO DRUG

Participants received ESPO by subcutaneous injection weekly. The starting dose was 6000 IU and was adjusted according to the instruction to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).

Also known as: Recombinant Human Erythropoietin Injection

ReHuman Erythropoietin Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years of age.
• Females of child-bearing potential who are sexually active had to be willing to practice a highly effective method of birth control for at least 4 weeks prior to randomization, and had to be willing to continue contraception until at least 4 weeks after the last dose of study treatment.
• CKD with an estimated glomerular filtration rate \< 60 mL/min/1.73m2 using Collaborative Group on Epidemiology of Chronic Kidney Diseases (CKD-EPI) formula within 4 weeks prior to randomization, and was not expected to begin dialysis for at least 12 weeks.
• The patient was not received any erythropoiesis stimulating agents (ESAs) treatment within 12 weeks prior to randomization. And two consecutive hemoglobin values ≥ 6.0 g/dL and \< 10.0 g/dL within 4 weeks prior to randomization.
• At least one transferrin saturation (TSAT) ≥ 20% or one serum ferritin (SF) level ≥ 100 ng/ml within 4 weeks prior to randomization. At least one serum folate level and vitamin B12 level ≥ lower limit of normal during the 4 weeks prior to randomization.
• Patient was informed of the investigational nature of the study and had given written, informed consent in accordance with institutional, local, and national guidelines.

You may not qualify if:

• Females who were pregnant or breast-feeding.
• Red blood cell (RBC) or whole blood transfusion within 12 weeks prior to randomization.
• Known intolerance to any ESA, parenteral iron supplementation, or PEGylated molecule.
• Known hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, hemoglobinopathy, pure red cell aplasia, hemolytic syndromes, coagulation disorder, etc.) or cause of anemia other than renal disease（e.g. gastrointestinal bleeding or hookworm disease for stool occult blood positive，etc.）.
• Known autoimmune diseases（e.g. rheumatoid arthritis, systemic lupus erythematosus, anti-neutrophil cytoplasmic antibody related vasculitis, etc.）.
• Obvious infection occurred within 4 weeks prior to randomization，per investigator's clinical judgment.
• Chronic, uncontrolled, or symptomatic inflammatory disease，per investigator's clinical judgment.
• Uncontrolled or symptomatic secondary hyperparathyroidism，per investigator's clinical judgment.
• Poorly controlled hypertension within 4 weeks prior to randomization, per investigator's clinical judgment.
• Chronic congestive heart failure (New York Heart Association Class III\~IV).
• Active hepatitis or any of the following check exceptions: ALT≥ 2 × upper limit of normal (ULN), AST≥ 2 × upper limit of normal (ULN), DBIL≥ 2 × upper limit of normal (ULN).
• A positive test for HIV antibody.
• Significant symptoms or diseases within 6 months prior to randomization，and the investigator judged that these diseases or symptoms may affect evaluation or follow-up.
• Currently receiving and requiring long-term immunosuppressive therapy.
• Tumor malignancy（non-melanoma skin cancer and carcinoma in situ that have been resected are excluded）.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Xie J, Yang A, Qiu H, Peng X, Lu W, Huang X, Chen Q, Zhong A, Tang S, Wang Q, Li C, He L, Jia X, Ma A, Wang F, Yu X. Randomized Trial of Pegmolesatide for the Treatment of Anemia in Patients With Nondialysis CKD. Kidney Int Rep. 2024 Dec 6;10(3):720-729. doi: 10.1016/j.ekir.2024.12.002. eCollection 2025 Mar.

  PMID: 40225393 DERIVED

Study Officials

• JunqiJunqi Chen, MD

  The First Affiliated Hospital, Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: April 4, 2019
• Study Start: June 20, 2019
• Primary Completion: October 14, 2021
• Study Completion: December 31, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

CN (1)