Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis

NCT03902691 | Completed Phase 3

• 1 other identifier: HS-20039-302
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effecacy and safety of dialysis centers switching its dialysis patients from using recombinant human erythropoietin injection (CHO Cell) (ESPO) to Pegol-Sihematide injection on hemoglobin levels and other parameters.

Conditions

Chronic Kidney Diseases

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 defined as the mean of three hemoglobin values: the 4 weeks and 2 weeks recent hemoglobin values taken prior to the day of randomization and the value obtained 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) or every 4 weeks (for the extensional treatment period).

  Week 17-24

Secondary Outcomes (4)

• Proportion of Patients Whose Hemoglobin Within ±1.0 g/dL of Baseline during the Evaluation Period

  Week 17-24

• Mean Dose of Participants With Hemoglobin Within ±1.0 g/dL of Baseline during the Evaluation Period

  Week 17-24

• Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period

  Week 17-24

• Average Hemoglobin, RBC, hematokrit and reticulocytes change from baseline

  Week 0-52

Other Outcomes (3)

• Safety Outcome Measures: adverse events

  Week 0-52

• Safety Outcome Measures: composite safety endpoint(CSE)

  Week 0-52

• Safety Outcome Measures: antibody

  Week 17-24

Study Arms (2)

Pegol-Sihematide

EXPERIMENTAL

Participants received Pegolsihematide by intravenous injection once every 4 weeks.

Drug: Pegol-Sihematide

ESPO (Recombinant Human Erythropoietin Injection）

ACTIVE COMPARATOR

ESPO administration 1 to 3 times per week.

Drug: ESPO

Interventions

Pegol-Sihematide DRUG

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

Pegol-Sihematide

ESPO DRUG

Participants received ESPO by subcutaneous injection or subcutaneous injection weekly. The dose was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 g/dL.

ESPO (Recombinant Human 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 and ≤70 years of age, weight ≥ 45 kilograms (kg).
• 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.
• Participants with chronic renal failure on dialysis（hemodialysis/ peritoneal dialysis） for ≥ 3 months prior to randomization，and that the frequency of dialysis was stable and no change in dialysis pattern was observed during the trial.
• On ESAs treatment for ≥8 weeks prior to screening stage with stable doses and the average doses ≤ 10000 IU/week. And two consecutive hemoglobin values ≥10.0 g/dL and ≤12.0 g/dL within 4 weeks prior to randomization.
• At least one transferrin saturation (TSAT) ≥ 20% and 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.
• Tumor malignancy（non-melanoma skin cancer and carcinoma in situ that have been resected are excluded）.
• 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.
• Expected survival less than 12 months.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Zhang P, Jiang Y, Xu C, Zhou L, Zheng H, Xie D, Guo M, Huang X, Lu G, Jiang H, Qiu H, Liu B, Li S, Chen Q, Xia Y, Sun B, Yang X, Zhang S, Du S, Sun M, Chen M, Zhong A, Wang X, Zhao Z, Zhou H, Li G, Ren Y, Luo Q, Yang A, Luo P, Tang S, Xu C, Wang Q, Wang X, Yan T, He W, Qin S, Zhang W, Lv L, Wang C, Liu H, Li J, Wu Q, Pan C, Li C, He L, Chen J. Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial. EClinicalMedicine. 2023 Oct 28;65:102273. doi: 10.1016/j.eclinm.2023.102273. eCollection 2023 Nov.

  PMID: 37954906 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianghua Chen, MD

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

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 13, 2019
• First Posted: April 4, 2019
• Study Start: May 15, 2019
• Primary Completion: February 28, 2021
• Study Completion: May 30, 2022
• Last Updated: March 9, 2023

Record last verified: 2022-02

Locations

CN (1)