RecruitingNot ApplicableNCT07136792

A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)

Efficacy and Safety of Pegmolesatide in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI): a Multi-center, Prospective, Open-label, Randomized Parallel Controlled Trial

Sponsor

Guangdong Provincial People's Hospital

Enrollment

96 participants

Start Date

Sep 8, 2025

Study Type

INTERVENTIONAL

Conditions

Renal Anemia of Chronic Kidney Disease

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new injectable medication called pegmolesatide for treating anemia (low red blood cell count) in people with chronic kidney disease who are on dialysis and already taking a medication called roxadustat (a pill that helps the body make more red blood cells). **You may be eligible if...** - You are 18 to 75 years old and weigh at least 45 kg - You have chronic kidney disease and have been on stable dialysis (hemodialysis or peritoneal dialysis) for at least 12 weeks - You are currently taking roxadustat at a stable dose - Your hemoglobin (a measure of red blood cells) is between 8.0 and 12.0 g/dL - Your iron levels are adequate **You may NOT be eligible if...** - You have an autoimmune condition or blood disorder unrelated to kidney disease - You have HIV/AIDS, active tuberculosis, or syphilis - You have poorly controlled blood pressure - You have received a blood transfusion in the past 12 weeks - You are pregnant, breastfeeding, or planning pregnancy - You are planning to have a kidney transplant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPegmolesatide 2mg SC

All patients will receive pegmolesatide 2mg subcutaneously once every 4 weeks.

DRUGPegmolesatide 4mg SC

All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.

DRUGPegmolesatide 4mg SC

All patients will receive pegmolesatide 4mg subcutaneously once every 4 weeks.

DRUGPegmolesatide 6mg SC

All patients will receive pegmolesatide 6mg subcutaneously once every 4 weeks.

Locations(24)

Beijing Hospital

Beijing, Beijing Municipality, China

Longyan First Hospital

Longyan, Fujian, China

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Yuebei People's Hospital

Shaoguan, Guangdong, China

Zhongshan Hospital of Traditional Chinese Medicine

Zhongshan, Guangdong, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Jingmen Central Hospital

Jingmen, Hubei, China

CNPG Dongfeng General Hospital

Shiyan, Hubei, China

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Wuhan Fourth Hospital

Wuhan, Hubei, China

Changsha Central Hospital

Changsha, Hunan, China

Nantong First People's Hospital

Nantong, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Baotou Medical College

Baotou, Neimenggu, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Yibin First People's Hospital

Yibin, Sichuan, China

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, China

Hangzhou Xiaoshan First People's Hospital

Hangzhou, Zhejiang, China

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

Rui'an People's Hospital

Wenzhou, Zhejiang, China

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