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

NCT07136792 | Recruiting DMC

• 1 other identifier: KY2025-667-03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Renal Anemia of Chronic Kidney Disease

Keywords

Renal Anemia

Outcome Measures

Primary Outcomes (1)

• Change of mean HB level

  Change of mean HB level from baseline to 12 weeks and 16 weeks

  from baseline to 12 weeks and 16 weeks

Secondary Outcomes (7)

• Change of mean HB level

  from baseline to 12 weeks and 16 weeks

• Changes in red blood cell count

  from baseline to 4 weeks, 8 weeks, 12 weeks, 16 weeks

• Median time to the first HB value reaching 10.0-12.0 g/dl

  From baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks

• Proportion of patients with HB 10.0-12.0 g/dl

  from baseline to 4 weeks, 8 weeks,12 weeks and 16 weeks

• Proportion of patients with HB 11.0-13.0 g/dl

  from baseline to 4 weeks, 8 weeks, 12 weeks and 16 weeks

Other Outcomes (1)

• The Maximum Plasma Concentration

  from the start of study drug to to 48 hours, 72 hours and 96 hours

Study Arms (4)

Arm A1: Pegmolesatide 2mg SC

EXPERIMENTAL

All patients in low-dose Roxadustat cohort randomised into this group will receive pegmolesatide 2mg subcutaneously once every 4 weeks.

Drug: Pegmolesatide 2mg SC

Arm A2: Pegmolesatide 4mg SC

EXPERIMENTAL

All patients in low-dose Roxadustat cohort randomised into this group will receive pegmolesatide 4mg subcutaneously once every 4 weeks.

Drug: Pegmolesatide 4mg SC

Arm B1: Pegmolesatide 4mg SC

EXPERIMENTAL

All patients in high-dose Roxadustat cohort randomised into this group will receive pegmolesatide 4mg subcutaneously once every 4 weeks.

Drug: Pegmolesatide 4mg SC

Arm B2: Pegmolesatide 6mg SC

EXPERIMENTAL

All patients in high-dose Roxadustat cohort randomised into this group will receive pegmolesatide 6mg subcutaneously once every 4 weeks.

Drug: Pegmolesatide 6mg SC

Interventions

Pegmolesatide 4mg SC DRUG

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

Arm A2: Pegmolesatide 4mg SC

Pegmolesatide 6mg SC DRUG

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

Arm B2: Pegmolesatide 6mg SC

Pegmolesatide 2mg SC DRUG

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

Arm A1: Pegmolesatide 2mg SC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-75 years, regardless of gender;
• Body weight ≥ 45 kg, and body mass index (BMI) ≥ 18.5 kg/m²;
• Diagnosis of chronic renal failure, and having undergone a stable regimen of peritoneal dialysis or hemodialysis for at least 12 weeks prior to enrollment (with stable hemofiltration at a frequency of every 2 or 4 weeks if applicable). Stable dialysis frequency and no plans to change the dialysis modality during the trial;
• An up to standard dialysis adequacy testing result before randomization: spKt/V ≥ 1.2 for hemodialysis, Kt/V ≥ 1.7 for peritoneal dialysis;
• Roxadustat dose ≤ 360 mg/week within 4 weeks before randomization, with stable dose; \[Stable dose is defined as: (the maximum weekly dose within 4 weeks before randomization - the average weekly dose within 4 weeks before randomization) ÷ the maximum weekly dose within 4 weeks before randomization ≤ 30%\];
• Two pre-dialysis HB test values within 4 weeks before randomization of 8.0 - 12.0 g/dl, with an absolute difference between the two Hb values ≤ 1.3 g/dl, and an interval of ≥ 7 days between the two HB tests;
• Serum ferritin level ≥ 100 μg/L and transferrin saturation (TAST) ≥ 20% at the time of testing before randomization, serum folate ≥ the lower limit of normal, and vitamin B12 ≥ the lower limit of normal;
• Understanding of the study procedures and voluntary signing of the written informed consent form.

You may not qualify if:

• Known autoimmune diseases, hematologic disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, and coagulation disorders), or other causes of anemia apart from CKD (such as gastrointestinal bleeding or hookworm disease).
• Confirmed diagnosis of acquired immunodeficiency syndrome (AIDS), syphilis, or tuberculosis and currently undergoing treatment.
• Known allergy to iron agents or polyethylene glycol molecules.
• Treatment history with ESAs in combination with HIF-PHIs drugs within 8 weeks prior to randomization.
• Underwent red blood cell or whole blood transfusion within 12 weeks prior to randomization.
• Poorly controlled blood pressure (uncontrolled hypertension is defined as: during the screening period, systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg in two or more blood pressure measurements, or although the blood pressure values are below the aforementioned criteria, the investigator deems it necessary to adjust antihypertensive medications).
• Active hepatitis or any of the following abnormal test results during the screening period (ALT ≥ 2 times the upper limit of normal, AST ≥ 2 times the upper limit of normal, DBIL ≥ 2 times the upper limit of normal, serum albumin \< 2.5 g/dl).
• Participants judged by the investigator to have uncontrolled or symptomatic secondary hyperparathyroidism, or those with blood iPTH \> 800 pg/mL during the screening period.
• C-reactive protein ≥ 30 mg/L during the screening period.
• Cardiac function assessed as NYHA Class III or IV during the screening period.
• Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
• Participants who plan to undergo kidney transplantation during the trial period or have already been kidney donors, or those who plan to undergo elective surgery during the trial period.
• Participants deemed by the investigator to have any other factors that make them unsuitable for participation in this trial.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (24)

Beijing Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Longyan First Hospital

Longyan, Fujian, China

NOT YET RECRUITING

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, China

NOT YET RECRUITING

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

NOT YET RECRUITING

Yuebei People's Hospital

Shaoguan, Guangdong, China

NOT YET RECRUITING

Zhongshan Hospital of Traditional Chinese Medicine

Zhongshan, Guangdong, China

NOT YET RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

NOT YET RECRUITING

Jingmen Central Hospital

Jingmen, Hubei, China

NOT YET RECRUITING

CNPG Dongfeng General Hospital

Shiyan, Hubei, China

NOT YET RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Wuhan Fourth Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

Changsha Central Hospital

Changsha, Hunan, China

NOT YET RECRUITING

Nantong First People's Hospital

Nantong, Jiangsu, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

NOT YET RECRUITING

The First Affiliated Hospital of Baotou Medical College

Baotou, Neimenggu, China

NOT YET RECRUITING

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

NOT YET RECRUITING

Yibin First People's Hospital

Yibin, Sichuan, China

NOT YET RECRUITING

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Hangzhou Xiaoshan First People's Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

NOT YET RECRUITING

Rui'an People's Hospital

Wenzhou, Zhejiang, China

NOT YET RECRUITING

Study Officials

• Xueqing Yu

  Guangdong Provincial People's Hospital

  STUDY CHAIR

• Zhiming Ye

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Xueqing Yu

CONTACT

+86-20-83827812; yuxueqing@gdph.org.cn

Zhiming ye

CONTACT

138 2616 1678; yezhiming@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 22, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (24)