Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial.
Ping Zhang, Yan Jiang, Chunping Xu...
https://pubmed.ncbi.nlm.nih.gov/37954906Actively Recruiting
Phase 4
Age: 18Years - 80Years
All Genders
ID07045155
Pegmolesatide for Anemia Treatment: Investigation Upgrade Therapy in rhuEPO Patients Undergoing Dialysis A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study (PANGU-stepup)
Led by Chinese PLA General Hospital · Updated on 2025-09-12
240
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
J
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for anemia in patients with dialysis-dependent chronic kidney disease (DD-CKD) who have been receiving recombinant human erythropoietin (rHuEPO) but have hemoglobin levels below target. The study is a prospective, multicenter, parallel-controlled, open-label trial conducted in several research centers across China. It aims to assess the effects of three treatment regimens on hemoglobin levels over 24 weeks among 240 patients aged 18 to 80 years. Participants will be randomly assigned to one of three groups: the experimental group receiving Pegmolesatide alone for 24 weeks; the control group treated with rHuEPO for 16 weeks followed by Pegmolesatide for 8 weeks; and an exploratory group receiving a combination of Pegmolesatide and roxadustat for 24 weeks. The study includes a screening phase (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension phase (Week 17 to Week 24). Throughout the study, researchers will monitor hemoglobin levels and other blood parameters at regular intervals to evaluate treatment effects. Safety and dosage adjustments will be tracked. The primary outcome is the change in mean hemoglobin from baseline at weeks 12 to 16. Secondary measures include proportions of participants reaching specific hemoglobin ranges, time to target hemoglobin, red blood cell counts, and rescue therapy use. The total participation duration is about 24 weeks, including screening and follow-up.
CONDITIONS
Brief Title
Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 years to 80 years, any gender
- Body weight of at least 40 kg and body mass index (BMI) of 18 kg/m�b2 or higher
- Receiving hemodialysis or peritoneal dialysis for 3 months or more before enrollment
- Receiving erythropoiesis-stimulating agents (ESAs) for at least 4 weeks before randomization, with an average weekly dose over 6000 IU in the last 4 weeks
- Hemoglobin levels between 70 g/L and less than 110 g/L during screening and baseline
- Hemodialysis patients with serum ferritin levels of at least 200 bcg/L; peritoneal dialysis patients with serum ferritin levels of at least 100 bcg/L and no planned kidney transplant during the trial
- Able to understand study procedures and voluntarily sign the informed consent form
You will not qualify if you...
- Active cancer, polycystic kidney disease, blood disorders including congenital and acquired anemias, or other anemia causes like gastrointestinal bleeding or hookworm disease
- Stroke, transient ischemic attack, heart attack, blood clots, or serious lung and heart disease within the last 6 months
- Use of anabolic steroids within 12 weeks before randomization
- Received red blood cell or whole blood transfusion within 12 weeks before the study
- Recent serious infection within 4 weeks before randomization
- High blood pressure readings (systolic 2180 mmHg or diastolic 110 mmHg) on multiple days within 4 weeks before enrollment, or changes in blood pressure medication
- Allergy to iron agents or polyethylene glycol
- Pregnant or breastfeeding, positive pregnancy test before the trial, or planning pregnancy during the study
- Scheduled for elective surgery during the trial
- Any other factors deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants receive drug treatment for anemia related to dialysis-dependent chronic kidney disease. Depending on the group, treatment involves rHuEPO, Pegmolesatide, or a combination of Pegmolesatide and roxadustat.
Visits during the 24-week treatment and observation period, including an initial 16-week treatment phase and an 8-week extension phase
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
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Research Team
P
Ping Li, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Randomized Trial of Pegmolesatide for the Treatment of Anemia in Patients With Nondialysis CKD.
Jianteng Xie, Aicheng Yang, Hongyu Qiu...
https://pubmed.ncbi.nlm.nih.gov/40225393