Actively Recruiting
A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)
Led by Guangdong Provincial People's Hospital · Updated on 2026-01-15
96
Participants Needed
24
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For patients with renal anemia treated with hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), there is a clinical need of switching to long-acting and safe medications. Pegmolesatide, a polyethylene glycol (PEG)-conjugated erythropoiesis-stimulating peptide, is a long-acting erythropoiesis-stimulating agent (ESA) with sustained activity. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2023. Phase III clinical trials have demonstrated its efficacy and safety in dialysis patients with renal anemia who were previously treated with recombinant human erythropoietin (rHuEPO). However, there are currently no data regarding the efficacy and safety of switching from HIF-PHIs to pegmolesatide, and there is a lack of standard for the dose conversion. This study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial, planning to enroll 96 patients. All enrolled patients will receive 12 weeks of treatment and be followed up for 16 weeks.
CONDITIONS
Official 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 and 75 years, any gender
- Body weight at least 45 kg and BMI at least 18.5 kg/m²
- Diagnosed with chronic renal failure and on stable peritoneal dialysis or hemodialysis for at least 12 weeks
- Stable dialysis frequency with no planned changes during the study
- Dialysis adequacy test results: spKt/V ≥ 1.2 for hemodialysis or Kt/V ≥ 1.7 for peritoneal dialysis
- Weekly Roxadustat dose ≤ 360 mg with stable dosing 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 and at least 7 days apart
- Serum ferritin ≥ 100 µg/L and transferrin saturation ≥ 20% before randomization
- Serum folate and vitamin B12 levels above the lower limit of normal
- Able to understand study procedures and provide informed consent
You will not qualify if you...
- Known autoimmune diseases or hematologic disorders unrelated to chronic kidney disease anemia
- Diagnosed with AIDS, syphilis, or tuberculosis and currently receiving treatment
- Allergy to iron agents or polyethylene glycol molecules
- Used erythropoiesis-stimulating agents combined with HIF-PHI drugs within 8 weeks before randomization
- Received red blood cell or whole blood transfusion within 12 weeks before randomization
- Poorly controlled blood pressure during screening (systolic >180 mmHg or diastolic >110 mmHg)
- Active hepatitis or abnormal liver function tests (ALT, AST, DBIL ≥ 2 times upper limit; albumin < 2.5 g/dl)
- 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, breastfeeding, or planning pregnancy during the study
- Planning kidney transplantation or elective surgery during the trial, or previous kidney donors
- Any other factors judged by the investigator that make participation unsuitable
AI-Screening
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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
CONTACT
Z
Zhiming ye
CONTACT
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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