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

Phase 4Not Yet RecruitingNCT06946394

The First Affiliated Hospital of Dalian Medical University160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Renal Anemia in Non-dialysis Chronic Kidney Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Baseline Hb was defined as the assessments of Hb during 3days prior to first dose of the study treatment. Mean Hb levels at week 24 of the treatment period (Hb at week 24) was defined as the mean of Hb at day 168±5 of the treatment period. 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 was calculated by subtracting the baseline Hb from Hb at week 24.

Time frame: the 24th week of treatment.