Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis

The First Affiliated Hospital of Dalian Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Renal Anemia in Non-dialysis Chronic Kidney Disease

Treatments: Drug: Pegmolesatide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06946394

HSM-20039-402

Details and patient eligibility

About

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.

Full description

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 were randomized in a 1:1 ratio to Pegmolesatide optimize medication regimen group and Pegmolesatide standard medication regimen group. Patients in the investigational group received 2.0 mg (in patients weighing ≤60 kg) or 3.2 mg (in patients weighing >60 kg) as the initial dose, the initial dose of the control group was 0.04mg/kg, then were adjusted for every 4 weeks based on Hb levels and its changes. The primary endpoint was the change in Hb levels from baseline in week 24.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old and ≤ 80 years old, gender not limited;
2. Weight ≥ 45kg; Body Mass Index (BMI) ≥ 18.5kg/m^2;
3. 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;
4. rHuEPO or HIF-PHI should be used for ≥ 4 weeks and ≤ 12 weeks;
5. During the 28days and 3days before randomization, with Hb ≥ 70g/L and < 110g/L;
6. Understand the research procedure and voluntarily sign an informed consent form (ICF) in writing.

Exclusion criteria

1. 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;
2. Known to be allergic to iron agents or polyethylene glycol;
3. Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;
4. Have received oral or intravenous immunosuppressive or glucocorticoid therapy within the 12 weeks prior to randomization;
5. Individuals with poor blood pressure control;
6. C-reactive protein ≥ 30mg/L within the first 3 days of randomization;
7. 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;
8. Assessment of cardiac function level III or IV within the first 3 days of randomization;
9. Within the first 3 days of randomization, the liver function was assessed as Grade C;
10. Researchers believe that subjects with any other factors that are not suitable for participating in this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Pegmolesatide optimize medication regimen group

Experimental group

Description:

initial phase：Body weight ≤60kg, initial dose 2.0mg; Body weight \> 60kg, initial dose 3.2mg, once every 4 weeks by subcutaneous injection. Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection.

Treatment:

Drug: Pegmolesatide

Pegmolesatide standard medication regimen group

Active Comparator group

Description:

initial phase：0.04mg/kg body weight, once every 4 weeks by subcutaneous injection. Adjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection.

Treatment:

Drug: Pegmolesatide