RecruitingPhase 4NCT07045155

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)


Sponsor

Chinese PLA General Hospital

Enrollment

240 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing pegmolesatide, a new monthly injection drug for anemia (low red blood cell count) in people on long-term dialysis who are currently on older anemia medications (called ESAs, like erythropoietin). The goal is to see if this drug can better control anemia with less frequent dosing. **You may be eligible if...** - You are between 18 and 80 years old on hemodialysis or peritoneal dialysis for at least 3 months - You are currently taking ESA injections for anemia with suboptimal response - Your hemoglobin (blood count) is in a specific low-to-moderate range - You have adequate iron stores **You may NOT be eligible if...** - You have active cancer, a blood disorder, or other cause of anemia (like bleeding) - You had a stroke, heart attack, blood clot, or pulmonary embolism in the past 6 months - You received blood transfusions or anabolic steroids recently - You are pregnant or planning to become pregnant - You have very high, uncontrolled blood pressure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGThe 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.

DRUGThe 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.

DRUGThe Pegmolesatide Monotherapy Group (Experimental group)

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


Locations(1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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NCT07045155


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