Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis

NCT06946394 | Not Yet Recruiting Phase 4

• 1 other identifier: HSM-20039-402
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.

Conditions

Renal Anemia in Non-dialysis Chronic Kidney Disease

Keywords

Anemia

Outcome Measures

Primary Outcomes (1)

• Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period.

  Baseline Hb was defined as the assessments of Hb during 3days prior to first dose of the study treatment. Mean Hb levels at week 24 of the treatment period (Hb at week 24) was defined as the mean of Hb at day 168±5 of the treatment period. Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period was calculated by subtracting the baseline Hb from Hb at week 24.

  the 24th week of treatment.

Secondary Outcomes (14)

• Median time for two groups of Hb values to reach the target for the first time

  during the 48 weeks of treatment.

• Proportion of subjects with Hb levels meeting the standard in two groups at each follow-up point

  during the 48 weeks of treatment.

• Change of Hb from baseline at each follow-up point

  during the 48 weeks of treatment.

• Change of red blood cell count from baseline at each follow-up point

  during the 48 weeks of treatment.

• Change of hematocrit from baseline at each follow-up point

  during the 48 weeks of treatment.

Study Arms (2)

Pegmolesatide optimize medication regimen group

EXPERIMENTAL

initial phase：Body weight ≤60kg, initial dose 2.0mg; Body weight \> 60kg, initial dose 3.2mg, once every 4 weeks by subcutaneous injection. Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection.

Drug: Pegmolesatide

Pegmolesatide standard medication regimen group

ACTIVE COMPARATOR

initial phase：0.04mg/kg body weight, once every 4 weeks by subcutaneous injection. Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection.

Drug: Pegmolesatide

Interventions

Pegmolesatide DRUG

Pegmolesatide Injection: Specification 1mL: 4.0mg (National Medical Products Administration Approval No. H20230020), administered once every 4 weeks

Also known as: EPO-018B

Pegmolesatide optimize medication regimen group; Pegmolesatide standard medication regimen 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:

• Age ≥ 18 years old and ≤ 80 years old, gender not limited;
• Weight ≥ 45kg; Body Mass Index (BMI) ≥ 18.5kg/m\^2;
• Diagnosed with CKD ≥ 6 months and estimated glomerular filtration rate (eGFR) ≥ 15mL/min/1.73m\^2 before enrollment, and\<60 mL/min/1.73m\^2 (estimated GFR using CKD-EPI formula), with no expected renal replacement therapy plan during the study period;
• rHuEPO or HIF-PHI should be used for ≥ 4 weeks and ≤ 12 weeks;
• During the 28days and 3days before randomization, with Hb ≥ 70g/L and \< 110g/L;
• Understand the research procedure and voluntarily sign an informed consent form (ICF) in writing.

You may not qualify if:

• Known to have hematological disorders or other diseases that cause anemia other than chronic kidney disease (CKD), such as primary pure red cell aplasia (PRCA), homozygous sickle cell disease, thalassemia/Cooley's anemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome, or malignant tumors;
• Known to be allergic to iron agents or polyethylene glycol;
• Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;
• Have received oral or intravenous immunosuppressive or glucocorticoid therapy within the 12 weeks prior to randomization;
• Individuals with poor blood pressure control;
• C-reactive protein ≥ 30mg/L within the first 3 days of randomization;
• Pregnant and lactating women, women of childbearing age who have a positive urine β - HCG test result before the trial, or those who have a pregnancy plan during the study period;
• Assessment of cardiac function level III or IV within the first 3 days of randomization;
• Within the first 3 days of randomization, the liver function was assessed as Grade C;
• Researchers believe that subjects with any other factors that are not suitable for participating in this trial.

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead
• Jiangsu Hansoh Pharmaceutical Co., Ltd.: collaborator

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 BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hongli Lin, M.D.

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongli Lin, M.D.

CONTACT

13332268576; linhongli@vip.163.com

Jilin Chen, M.D.

CONTACT

18098875658

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: April 27, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share