Tests pegmolesatide for anemia in adults on long-term dialysis
Compares pegmolesatide with rHuEPO in dialysis patients with chronic kidney disease and anemia.
Plain-language title generated from the registry record
Registry title: Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who have anemia and have been on dialysis for at least 3 months. They must have been taking ESAs such as rHuEPO for at least 4 weeks.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Anemia in dialysis-dependent chronic kidney disease. Hemoglobin of 70 g/L or more and below 110 g/L. On hemodialysis or peritoneal dialysis for 3 months or more.
- Earlier treatment
- Must have taken erythropoiesis-stimulating agents (ESAs) for at least 4 weeks, with an average weekly dose above 6000 IU in the last 4 weeks. No anabolic steroids in the 12 weeks before randomization. No blood transfusion in the last 12 weeks.
- Biomarker or test result
- Serum ferritin of 200 μg/L or more for hemodialysis patients. Serum ferritin of 100 μg/L or more for peritoneal dialysis patients. Body weight of 40 kg (88 lb) or more and BMI of 18 kg/m² or more.
Main reasons for not taking part
- Active cancer, polycystic kidney disease, blood disorders or other causes of anemia
- Stroke, heart attack, blood clots or other serious heart or lung disease in the past 6 months
- Serious infection in the 4 weeks before randomization
- Very high blood pressure (180/110 mmHg or above) in the 4 weeks before enrollment
- Pregnant or breastfeeding women, or allergy to iron agents or polyethylene glycol
This trial only enrols participants on dialysis. The registry sentence this rests on: Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07045155, who can take part
Where in China
- Chinese PLA General HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese PLA General Hospital
- Trial code
- NCT07045155
- Record updated
- 12 September 2025
- Original description
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.Read full original descriptionShow less
Pegmolesatide for Anemia Treatment：Investigation Upgrade Therapy in rhuEPO Patients Undergoing Dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-stepup）
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.
Inclusion: 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).
Exclusion: 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; Scheduled for elective surgery during the trial period; 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; 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; Presence of any other factors that the investigator deems unsuitable for participation in this trial.