Trials / Recruiting

RecruitingNCT07045155

Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis

Pegmolesatide for Anemia Treatment：Investigation Upgrade Therapy in rhuEPO Patients Undergoing Dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-stepup）

Status: Recruiting
Phase: Phase 4
Study type: Interventional
Enrollment: 240 (estimated)

Sponsor: Chinese PLA General Hospital · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

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.

Detailed description

title： Pegmolesatide for anemia treatment：investigation upgrade therapy in rhuEPO patients undergoing dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-upgrade） Introduction: Anemia is a primary complication of chronic kidney disease (CKD). In recent years, there have been many effective strategies for treating anemia in CKD, including erythropoiesis-stimulating agents (ESAs), hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), and erythropoietin (EPO) mimetic peptides (EMPs) such as Pegmolesatide. This study aims to explore the efficacy and safety of switching patients with anemia of dialysis-dependent chronic kidney disease (DD-CKD), whose hemoglobin (Hb) levels have not reached the target after treatment with recombinant human erythropoietin (rHuEPO), to treatment with pegmolesatide. Methods: This study is designed as a prospective, multicenter, parallel-controlled, open-label trial. It plans to enroll 240 participants with anemia of dialysis-dependent chronic kidney disease (DD-CKD) who have been receiving recombinant human erythropoietin (rHuEPO) treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g/L and \<110 g/L. Participants will be randomly assigned in a 1:1:1 ratio to the experimental group, the control group, and the exploratory group. The study will consist of a 24-week treatment and observation period, divided into three phases: the screening period (Day -28 to Day -1), the treatment period (Week 0 to Week 16), and the extension period (Week 17 to Week 24). This study plans to recruit participants from 20 large tertiary hospitals across multiple provinces and cities in China. The primary endpoint of the study is the change in mean hemoglobin (Hb) levels from baseline at weeks 12 to 16 of treatment in the three groups. The study will observe and evaluate the efficacy and safety of switching patients with anemia of dialysis-dependent chronic kidney disease (DD-CKD) who have not achieved target Hb levels after treatment with recombinant human erythropoietin (rHuEPO) to treatment with pegmolesatide alone or pegmolesatide in combination with roxadustat.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2025-08-01
Primary completion: 2027-12-30
Completion: 2028-12-30
First posted: 2025-07-01
Last updated: 2025-09-12

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07045155. Inclusion in this directory is not an endorsement.