Actively Recruiting
Efficacy and Safety of Pegmolesatide in Dialysis Chronic Kidney Disease Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor: A Multi-center, Randomized, Open-label Trial
Led by Guangdong Provincial People's Hospital · Updated on 2026-01-15
96
Participants Needed
24
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of pegmolesatide, a long-acting erythropoiesis-stimulating agent (ESA), in patients with renal anemia who are currently treated with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs). This trial aims to explore the safety and effectiveness of switching from HIF-PHIs to pegmolesatide, addressing the current need for longer-acting and safe medications. The study is a multi-center, prospective, open-label, randomized parallel-controlled trial enrolling 96 dialysis chronic kidney disease patients with anemia. Participants are divided into two groups based on their current weekly Roxadustat dose: a low-dose cohort (≤210 mg) and a high-dose cohort (>210 mg and ≤360 mg). Within each cohort, patients are randomly assigned to receive pegmolesatide at different initial doses (2 mg, 4 mg, or 6 mg) administered subcutaneously once every 4 weeks. The dose may be adjusted according to the drug's instructions. The treatment period lasts 12 weeks, followed by a 16-week follow-up period. During the study, researchers will monitor hemoglobin levels and other blood parameters at various intervals to assess the effects of pegmolesatide. Patients will undergo assessments including hemoglobin tests, red blood cell counts, and safety monitoring for adverse events. The primary measurement is the change in mean hemoglobin levels from baseline to 12 and 16 weeks. The total participation time for each patient is 28 weeks, including treatment and follow-up.
CONDITIONS
Brief Title
A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18-75 years, regardless of gender
- Body weight at least 45 kg and body mass index 18.5 kg/m² or higher
- Diagnosis of chronic renal failure with at least 12 weeks of stable peritoneal dialysis or hemodialysis
- Stable dialysis adequacy: spKt/V ≥ 1.2 for hemodialysis or Kt/V ≥ 1.7 for peritoneal dialysis
- Roxadustat dose ≤ 360 mg/week with stable dose in the 4 weeks before randomization
- Two pre-dialysis hemoglobin tests within 4 weeks before randomization between 8.0 and 12.0 g/dl with ≤ 1.3 g/dl difference
- Serum ferritin ≥ 100 µg/L and transferrin saturation ≥ 20%, with normal serum folate and vitamin B12 levels
- Ability to understand study procedures and provide written informed consent
You will not qualify if you...
- Known autoimmune diseases, hematologic disorders, or causes of anemia other than chronic kidney disease
- Current treatment for AIDS, syphilis, or tuberculosis
- Allergy to iron agents or polyethylene glycol molecules
- Treatment with erythropoiesis-stimulating agents combined with HIF-PHI drugs within 8 weeks before randomization
- Red blood cell or whole blood transfusion within 12 weeks before randomization
- Poorly controlled high blood pressure or need to adjust antihypertensive medications
- Active hepatitis or abnormal liver function tests during screening
- Uncontrolled or symptomatic secondary hyperparathyroidism or blood iPTH > 800 pg/mL
- C-reactive protein ≥ 30 mg/L during screening
- Cardiac function classified as NYHA Class III or IV
- Pregnant or breastfeeding women, or planning pregnancy during the study
- Planning kidney transplantation or 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments
Duration - 12 weeks
Participants receive pegmolesatide injections subcutaneously once every 4 weeks for 12 weeks, with dosage adjusted as needed.
4 visits (in-person) for pegmolesatide administration and monitoring
Duration - 16 weeks
Participants are followed for safety and efficacy monitoring for 16 weeks after treatment ends.
Visits scheduled at 4-week intervals during follow-up for assessments
Trial Site Locations
Total: 24 locations
1
Beijing Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Longyan First Hospital
Longyan, Fujian, China
Not Yet Recruiting
3
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Not Yet Recruiting
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
5
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
6
Meizhou People's Hospital
Meizhou, Guangdong, China
Not Yet Recruiting
7
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Not Yet Recruiting
8
Yuebei People's Hospital
Shaoguan, Guangdong, China
Not Yet Recruiting
9
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong, China
Not Yet Recruiting
10
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Not Yet Recruiting
11
Jingmen Central Hospital
Jingmen, Hubei, China
Not Yet Recruiting
12
CNPG Dongfeng General Hospital
Shiyan, Hubei, China
Not Yet Recruiting
13
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
14
Wuhan Fourth Hospital
Wuhan, Hubei, China
Not Yet Recruiting
15
Changsha Central Hospital
Changsha, Hunan, China
Not Yet Recruiting
16
Nantong First People's Hospital
Nantong, Jiangsu, China
Not Yet Recruiting
17
The First Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
18
The First Affiliated Hospital of Baotou Medical College
Baotou, Neimenggu, China
Not Yet Recruiting
19
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Not Yet Recruiting
20
Yibin First People's Hospital
Yibin, Sichuan, China
Not Yet Recruiting
21
Tianjin First Center Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
22
Hangzhou Xiaoshan First People's Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
23
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Not Yet Recruiting
24
Rui'an People's Hospital
Wenzhou, Zhejiang, China
Not Yet Recruiting
Research Team
X
Xueqing Yu
Z
Zhiming ye
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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