Actively Recruiting
Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis
Led by Chinese PLA General Hospital · Updated on 2025-09-12
240
Participants Needed
1
Research Sites
178 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
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.
CONDITIONS
Official Title
Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- Body weight of at least 40 kg and body mass index (BMI) of at least 18 kg/m
- Receiving hemodialysis or peritoneal dialysis for at least 3 months 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 (Hb) levels between 70 g/L and less than 110 g/L during screening and baseline visits
- 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 renal transplant during the trial
- Ability to understand study procedures and voluntarily sign informed consent
You will not qualify if you...
- Active malignancy, polycystic kidney disease, hematologic disorders (including congenital and acquired anemias), or other causes of anemia such as gastrointestinal bleeding or hookworm disease
- Stroke, transient ischemic attack, myocardial infarction, thromboembolic events, pulmonary embolism, or serious cardiopulmonary disease within the last 6 months
- Anabolic steroid therapy within 12 weeks prior to randomization
- Red blood cell or whole blood transfusion within 12 weeks prior to the study
- Significant infection within 4 weeks before randomization
- High blood pressure with systolic e9 180 mmHg or diastolic e9 110 mmHg within 4 weeks before enrollment
- Allergy to iron agents or polyethylene glycol
- Pregnant or breastfeeding women, women with positive blood b2-HCG test before the trial, or planning pregnancy during the study
- Scheduled elective surgery during the trial
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
P
Ping Li, M.D.
CONTACT
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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