Switching to pegmolesatide for anemia in people on dialysis

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

This 24-week test will try whether switching dialysis patients whose anemia isn't at goal from rHuEPO to pegmolesatide alone or combined with roxadustat keeps or raises hemoglobin better than continuing rHuEPO.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07045155 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label, randomized 1:1:1 trial enrolling 240 dialysis-dependent CKD patients with renal anemia who have been on rHuEPO for at least 4 weeks and have hemoglobin between 70 and <110 g/L. Participants will be assigned to continue rHuEPO (control), switch to pegmolesatide monotherapy (experimental), or switch to pegmolesatide plus roxadustat (exploratory) and followed for 24 weeks including screening, treatment, and an extension period. The primary outcome compares hemoglobin changes across the three regimens, with safety and tolerability monitored throughout. The trial is open-label and conducted at multiple centers in China, led by the Chinese PLA General Hospital.

Who should consider this trial

Good fit: Adults 18–80 years on hemodialysis or peritoneal dialysis for ≥3 months, weighing ≥40 kg with BMI ≥18 kg/m², receiving ESAs for ≥4 weeks (equivalent short-acting EPO >6000 IU/week), and with screening and baseline Hb between 70 and <110 g/L and adequate ferritin levels per dialysis modality.

Not a fit: Patients not on maintenance dialysis, those with Hb below 70 g/L or ≥110 g/L, those with insufficient iron stores, or those needing imminent renal transplant are unlikely to match the study population or obtain benefit from the study interventions.

Why it matters

Potential benefit: If successful, this approach could provide dialysis patients an alternative ESA option that maintains or improves hemoglobin control, potentially with different dosing or convenience.

How similar studies have performed: Erythropoiesis-stimulating agents and some EPO-mimetic peptides have corrected renal anemia in prior trials, though agents in this class have sometimes shown safety issues, so newer switching strategies are being re-examined.

Eligibility criteria

Inclusion Criteria:

1. Aged ≥18 years and ≤80 years, with no restrictions on gender.
2. Body weight ≥40 kg and body mass index (BMI) ≥18 kg/m².
3. Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;
4. 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);
5. 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;
6. 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;
7. Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF).

Exclusion Criteria:

1. 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);
2. 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;
3. Received anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization;
4. Known to have received red blood cell or whole blood transfusion within 12 weeks prior to the study.
5. History of significant infection within 4 weeks before randomization as determined by the investigator.
6. 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.
7. Known allergy to iron agents or polyethylene glycol.
8. 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.
9. Scheduled for elective surgery during the trial period.
10. Presence of any other factors that the investigator deems unsuitable for participation in this trial.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xiangmei Chen — Chinese PLA General Hospital
• Study coordinator: Ping Li, M.D.

Conditions: Dialysis, Complications, Chronic Kidney Disease 5D, Renal Anemia of Chronic Kidney Disease, Renal Anaemia, Renal Anemia, Chronic, recombinant human erythropoietin, erythropoietin mimetic peptides