Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis

NCT07045155 | Recruiting Phase 4

• 1 other identifier: HS-20039-404
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, multicenter, parallel-controlled, open-label clinical trial, planned to be conducted across multiple research centers in various provinces and cities in China. It will enroll 240 dialysis-dependent chronic kidney disease (DD-CKD) patients with anemia who have been receiving rHuEPO treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g/L and \<110 g/L. After enrollment, participants will be randomly assigned in a 1:1:1 ratio to the experimental group, control group, and exploratory group. The study will involve a 24-week treatment and observation period, divided into three phases: a screening period (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension period (Week 17 to Week 24). The primary objective is to assess the impact of the three treatment regimens on the hemoglobin levels of patients with DD-CKD anemia.

Conditions

Dialysis; Complications; Chronic Kidney Disease 5D; Renal Anemia of Chronic Kidney Disease; Renal Anaemia; Renal Anemia, Chronic

Keywords

recombinant human erythropoietin; erythropoietin mimetic peptides; Pegmolesatide; Dialysis; renal anemia

Outcome Measures

Primary Outcomes (1)

• The change in mean hemoglobin (Hb) levels from baseline at weeks 12 to 16 of treatment in the three groups.

  Primary efficacy endpoints

  During weeks 12 to 16 of the study treatment

Secondary Outcomes (15)

• The proportion of participants in the three groups with mean Hb levels ≥100 g/L and ≤120 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.

  During weeks 12 to 16 and weeks 20 to 24 of the study treatment

• The proportion of participants in the three groups with mean Hb levels ≥110 g/L and ≤130 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.

  During weeks 12 to 16 and weeks 20 to 24 of the study treatment

• The proportion of participants in the three groups with mean Hb levels ≥100 g/L at weeks 12 to 16 and weeks 20 to 24 of treatment.

  During weeks 12 to 16 and weeks 20 to 24 of the study treatment

• The proportion of participants in the three groups with mean Hb levels ≥110 g/L at weeks 12 and 24 of treatment.

  at weeks 12 and 24 of treatment.

• The median time to first reach the target Hb level (110-130 g/L) during the treatment period in the three groups.

  up to 24 weeks

Other Outcomes (6)

• Artificial intelligence (AI)-predicted rational dosing regimens for medications.

  through study completion, an average of 1 year

• The change in carbamylated EPO levels from baseline at week 16 of treatment in the three groups.

  The change from baseline data at week 16 of treatment

• Subgroup analysis based on different baseline characteristics

  up to 24 weeks

Study Arms (3)

The Pegmolesatide Monotherapy Group (Experimental Group)

EXPERIMENTAL

The Pegmolesatide Monotherapy Group (Experimental Group) will receive Pegmolesatide treatment throughout the entire 24-week period.

Drug: The Pegmolesatide Monotherapy Group (Experimental group)

The rHuEPO Monotherapy Group (Control Group)

ACTIVE COMPARATOR

The rHuEPO Monotherapy Group (Control Group) will be treated with rHuEPO for the first 16 weeks and then switch to Pegmolesatide treatment for the subsequent 8 weeks.

Drug: The rHuEPO Monotherapy Group (Control Group)

The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group)

ACTIVE COMPARATOR

The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) will receive a combination of Pegmolesatide and roxadustat throughout the entire 24-week treatment period.

Drug: The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group)

Interventions

The rHuEPO Monotherapy Group (Control Group) DRUG

The rHuEPO Monotherapy Group (Control Group) will be treated with rHuEPO for the first 16 weeks and then switch to Pegmolesatide treatment for the subsequent 8 weeks.

Also known as: Control Group

The rHuEPO Monotherapy Group (Control Group)

The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) DRUG

The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group) will receive a combination of Pegmolesatide and roxadustat throughout the entire 24-week treatment period.

Also known as: Exploratory Group

The Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group)

The Pegmolesatide Monotherapy Group (Experimental group) DRUG

The Pegmolesatide Monotherapy Group (Experimental Group) will receive Pegmolesatide treatment throughout the entire 24-week period.

Also known as: Experimental group

The Pegmolesatide Monotherapy Group (Experimental Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years and ≤80 years, with no restrictions on gender.
• Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m².
• Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;
• Subjects who have been receiving erythropoiesis-stimulating agents (ESAs) for ≥4 weeks prior to randomization, with an average weekly dose \>6000 IU in the last 4 weeks (equivalent dose converted to short-acting EPO \>6000 IU, calculated as the total amount of short-acting EPO used in the last 4 weeks divided by 4);
• The most recent Hb value during the screening period and the average Hb value between screening and baseline visits must be ≥70 to \<110 g/L;
• Hemodialysis patients with serum ferritin levels ≥200 μg/L; peritoneal dialysis patients with serum ferritin levels ≥100 μg/L, and the investigator determines that renal transplant is not required during the trial;
• Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF).

You may not qualify if:

• Known to have active malignancy, polycystic kidney disease, hematologic disorders (including congenital and acquired anemias such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndromes, hemolytic anemia, and coagulation disorders), or other causes of anemia (such as gastrointestinal bleeding or hookworm disease);
• Known to have experienced stroke, transient ischemic attack, myocardial infarction, thromboembolic events (deep vein thrombosis), pulmonary embolism, or other serious cardiopulmonary diseases within the past 6 months;
• Received anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization;
• Known to have received red blood cell or whole blood transfusion within 12 weeks prior to the study.
• History of significant infection within 4 weeks before randomization as determined by the investigator.
• Confirmed blood pressure measurements at rest and in a conscious state using standard measurement methods, with at least three non-consecutive day readings reaching or exceeding systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg within 4 weeks before enrollment, or changes in antihypertensive medication treatment. The primary basis for judgment is clinic-measured blood pressure values, but "white coat hypertension" should be excluded.
• Known allergy to iron agents or polyethylene glycol.
• Pregnant or breastfeeding women, women of childbearing age with a positive blood β-HCG test result before the trial, or those planning to become pregnant during the study period.
• Scheduled for elective surgery during the trial period.
• Presence of any other factors that the investigator deems unsuitable for participation in this trial.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Jiangsu Hansoh Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xiangmei Chen

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Li, M.D.

CONTACT

+8615810136659; liping.8@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician of the Chinese Academy of Engineering, Chief Physician, Professor, and Doctoral

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: July 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)