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Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis

NCT07045155 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-09-12

No results posted yet for this study

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

Interventions

DRUG

The rHuEPO Monotherapy Group (Control Group)

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 Pegmolesatide and Roxadustat Combination Therapy Group (Exploratory Group)

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 Monotherapy Group (Experimental group)

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

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Xiangmei Chen · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045155 on ClinicalTrials.gov