A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pegmolesatide 2mg SC: All patients will receive pegmolesatide 2mg subcutaneously once every 4 weeks.
Pegmolesatide 4mg SC: All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.
Pegmolesatide 4mg SC: All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.
Pegmolesatide 6mg SC: All patients will receive pegmolesatide 6mg subcutaneously once every 4 weeks.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Change of mean HB level — from baseline to 12 weeks and 16 weeks
Change of mean HB level from baseline to 12 weeks and 16 weeks
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| Longyan First Hospital | Longyan | Fujian | Not Yet Recruiting |
| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Fujian | Not Yet Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| Meizhou People's Hospital | Meizhou | Guangdong | Not Yet Recruiting |
| The First Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | Not Yet Recruiting |
| Yuebei People's Hospital | Shaoguan | Guangdong | Not Yet Recruiting |
| Zhongshan Hospital of Traditional Chinese Medicine | Zhongshan | Guangdong | Not Yet Recruiting |
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | Not Yet Recruiting |
| Jingmen Central Hospital | Jingmen | Hubei | Not Yet Recruiting |
| CNPG Dongfeng General Hospital | Shiyan | Hubei | Not Yet Recruiting |
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | Recruiting |
| Wuhan Fourth Hospital | Wuhan | Hubei | Not Yet Recruiting |
| Changsha Central Hospital | Changsha | Hunan | Not Yet Recruiting |
| Nantong First People's Hospital | Nantong | Jiangsu | Not Yet Recruiting |
| The First Hospital of China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| The First Affiliated Hospital of Baotou Medical College | Baotou | Neimenggu | Not Yet Recruiting |
| The First Affiliated Hospital of Shandong First Medical University | Jinan | Shandong | Not Yet Recruiting |
| Yibin First People's Hospital | Yibin | Sichuan | Not Yet Recruiting |
| Tianjin First Center Hospital | Tianjin | Tianjin Municipality | Not Yet Recruiting |
| Hangzhou Xiaoshan First People's Hospital | Hangzhou | Zhejiang | Not Yet Recruiting |
| The Affiliated People's Hospital of Ningbo University | Ningbo | Zhejiang | Not Yet Recruiting |
| Rui'an People's Hospital | Wenzhou | Zhejiang | Not Yet Recruiting |
More Guangdong Provincial People's Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07136792 on ClinicalTrials.gov ↗ ← All trials in China