Switching dialysis patients on HIF-PHI to long‑acting pegmolesatide for renal anemia

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

This study will test whether switching dialysis patients with renal anemia who are taking HIF‑PHI medication to long‑acting pegmolesatide keeps hemoglobin stable and is safe.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (other)
• Locations: 24 sites (Beijing, Beijing Municipality and 23 other locations)
• Trial ID: NCT07136792 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, open‑label, randomized, parallel‑controlled trial enrolling 96 dialysis patients with renal anemia who are on stable HIF‑PHI therapy. Patients are split into two cohorts by their weekly roxadustat dose (≤210 mg and >210–≤360 mg) and further stratified by hemoglobin (<10.0 g/dL vs ≥10.0 g/dL) before randomization. Within each cohort patients are randomized 1:1 to predefined starting doses of subcutaneous pegmolesatide and followed through a 12‑week treatment period to compare hemoglobin control and safety. The study will collect efficacy, safety, and dose‑conversion data to inform switching recommendations.

Who should consider this trial

Good fit: Adults 18–75 years on stable hemodialysis or peritoneal dialysis for ≥12 weeks who weigh ≥45 kg with BMI ≥18.5 kg/m², are on a stable roxadustat dose ≤360 mg/week, and have recent hemoglobin values in the protocol range are ideal candidates.

Not a fit: Patients not currently treated with HIF‑PHI, those with unstable dialysis regimens or doses outside the protocol limits, or with contraindications to ESAs are unlikely to benefit from this switch.

Why it matters

Potential benefit: If successful, switching to pegmolesatide could provide a longer‑acting ESA option that maintains hemoglobin with fewer injections and clearer dose‑conversion guidance.

How similar studies have performed: Phase III trials have shown pegmolesatide is effective and safe in dialysis patients switching from rHuEPO, but there are no published data specifically on switching from HIF‑PHIs to pegmolesatide.

Eligibility criteria

Inclusion Criteria:

1. Age between 18-75 years, regardless of gender;
2. Body weight ≥ 45 kg, and body mass index (BMI) ≥ 18.5 kg/m²;
3. 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;
4. An up to standard dialysis adequacy testing result before randomization: spKt/V ≥ 1.2 for hemodialysis, Kt/V ≥ 1.7 for peritoneal dialysis;
5. Roxadustat dose ≤ 360 mg/week within 4 weeks before randomization, with stable dose; \[Stable dose is defined as: (the maximum weekly dose within 4 weeks before randomization - the average weekly dose within 4 weeks before randomization) ÷ the maximum weekly dose within 4 weeks before randomization ≤ 30%\];
6. 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;
7. 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;
8. Understanding of the study procedures and voluntary signing of the written informed consent form.

Exclusion Criteria:

1. 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).
2. Confirmed diagnosis of acquired immunodeficiency syndrome (AIDS), syphilis, or tuberculosis and currently undergoing treatment.
3. Known allergy to iron agents or polyethylene glycol molecules.
4. Treatment history with ESAs in combination with HIF-PHIs drugs within 8 weeks prior to randomization.
5. Underwent red blood cell or whole blood transfusion within 12 weeks prior to randomization.
6. 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).
7. 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).
8. Participants judged by the investigator to have uncontrolled or symptomatic secondary hyperparathyroidism, or those with blood iPTH \> 800 pg/mL during the screening period.
9. C-reactive protein ≥ 30 mg/L during the screening period.
10. Cardiac function assessed as NYHA Class III or IV during the screening period.
11. Pregnant or breastfeeding women, or those planning to become pregnant during the study period.
12. 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.
13. Participants deemed by the investigator to have any other factors that make them unsuitable for participation in this trial.

Where this trial is running

Beijing, Beijing Municipality and 23 other locations

• 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, 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 contacts

• Study coordinator: Xueqing Yu

Conditions: Renal Anemia of Chronic Kidney Disease, Renal Anemia