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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• 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

Study contacts

• Study coordinator: Xueqing Yu
• Email: yuxueqing@gdph.org.cn
• Phone: +86-20-83827812

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Switching to pegmolesatide for anemia in people on dialysis

  This 24-week test will try whether switching dialysis patients whose anemia isn't at goal from rHuEPO to pegmolesatide alone or combined with roxadustat keeps or raises hemoglobin better than continuing rHuEPO.

  Recruiting Phase 4 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07045155

• Switching to Pegmolesatide in non-dialysis CKD with renal anemia

  This study tests whether Pegmolesatide can improve anemia in adults with non-dialysis CKD who are already treated with rHuEPO or a HIF-PHI.

  Recruiting Phase 4 The First Affiliated Hospital of Dalian Medical University · Dalian, Liaoning · NCT06946394

• Enarodustat for Anemia in Non-Dialysis CKD Patients

  This study tests whether enarodustat can help increase hemoglobin safely in adults with CKD who aren’t on dialysis, grouping participants by inflammation level.

  Recruiting Huashan Hospital · Shanghai, Shanghai Municipality · NCT07741279

• Treatment of anemia in patients with chronic kidney disease on dialysis

  This study is testing if a new anemia treatment called efepoetin alfa works better than darbepoetin alfa for people with chronic kidney disease who are on dialysis.

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• Evaluating the safety of Desidustat for treating anemia in chronic kidney disease patients

  This study is testing the long-term safety of a medication called Desidustat for treating anemia in people with chronic kidney disease.

  Recruiting Phase 4 Zydus Lifesciences Limited · Sheikhpura, Bihar · NCT05515367

• AND017 for anemia in people on dialysis for chronic kidney disease

  This trial will test whether AND017 capsules can increase hemoglobin and be safe in adults on dialysis for end-stage kidney disease who have anemia, compared with standard ESA treatment.

  Recruiting Phase 3 Kind Pharmaceuticals LLC · Shanghai · NCT07494409

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.