Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not R… (NCT06946394) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis
160 participantsStarted 2025-05
Plain-language summary
This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years old and ≤ 80 years old, gender not limited;
. Weight ≥ 45kg; Body Mass Index (BMI) ≥ 18.5kg/m\^2;
. Diagnosed with CKD ≥ 6 months and estimated glomerular filtration rate (eGFR) ≥ 15mL/min/1.73m\^2 before enrollment, and\<60 mL/min/1.73m\^2 (estimated GFR using CKD-EPI formula), with no expected renal replacement therapy plan during the study period;
. rHuEPO or HIF-PHI should be used for ≥ 4 weeks and ≤ 12 weeks;
. During the 28days and 3days before randomization, with Hb ≥ 70g/L and \< 110g/L;
. Understand the research procedure and voluntarily sign an informed consent form (ICF) in writing.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes of mean Hb levels from baseline in the standard medication regimen group and the optimized medication regimen group at week 24 of the treatment period.
Timeframe: the 24th week of treatment.
Trial details
NCT IDNCT06946394
SponsorThe First Affiliated Hospital of Dalian Medical University
. Known to have hematological disorders or other diseases that cause anemia other than chronic kidney disease (CKD), such as primary pure red cell aplasia (PRCA), homozygous sickle cell disease, thalassemia/Cooley's anemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome, or malignant tumors;
. Known to be allergic to iron agents or polyethylene glycol;
. Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;
. Have received oral or intravenous immunosuppressive or glucocorticoid therapy within the 12 weeks prior to randomization;
. Individuals with poor blood pressure control;
. C-reactive protein ≥ 30mg/L within the first 3 days of randomization;
. Pregnant and lactating women, women of childbearing age who have a positive urine β - HCG test result before the trial, or those who have a pregnancy plan during the study period;
. Assessment of cardiac function level III or IV within the first 3 days of randomization;