Clinical trial NCT06946394: Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis
Official title: Application of Pegmolesatide in Renal Anemia: the Effectiveness and Safety of Switching to Two Different Regimens of Pegmolesatide in Patients With Non Dialysis CKD Treated With rhuEPO or HIF-PHI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Renal Anemia in Non-dialysis Chronic Kidney Disease
Keywords: Anemia
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu Hansoh Pharmaceutical Co., Ltd.
First posted: 2025-04-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Median time for two groups of Hb values to reach the target for the first time
timeFrame: during the 48 weeks of treatment.
measure: Proportion of subjects with Hb levels meeting the standard in two groups at each follow-up point
timeFrame: during the 48 weeks of treatment.
measure: Change of Hb from baseline at each follow-up point
timeFrame: during the 48 weeks of treatment.
measure: Change of red blood cell count from baseline at each follow-up point
timeFrame: during the 48 weeks of treatment.
measure: Change of hematocrit from baseline at each follow-up point
timeFrame: during the 48 weeks of treatment.
measure: the fluctuation of Hb values between the two groups after 24 weeks (Hb variability)
timeFrame: after the 24 weeks of treatment.
measure: The types and average doses of anti-anemia drugs of the subjects reaching the Hb target at each follow-up time point
timeFrame: during the 48 weeks of treatment.
measure: Cumulative number of dose adjustments for both groups of subjects in weeks 24 and 48
timeFrame: the 24th and 48th week of treatment.
measure: Therapeutic response of populations with different baseline characteristics to pegmolesatide
timeFrame: at the week 24 of treatment.
measure: Patient reported outcomes (PROs) at baseline and at week 24 in both groups
timeFrame: baseline and the 24th week of treatment
measure: All-cause death
timeFrame: during the 24/48 weeks of treatment.
measure: Cardiovascular death
timeFrame: during the 24/48 weeks of treatment.
measure: Cerebral infarction and myocardial infarction
timeFrame: during the 24/48 weeks of treatment.
measure: Receive regular renal replacement therapy
timeFrame: during the 24/48 weeks of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Hongli Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang P, Jiang Y, Xu C, Zhou L, Zheng H, Xie D, Guo M, Huang X, Lu G, Jiang H, Qiu H, Liu B, Li S, Chen Q, Xia Y, Sun B, Yang X, Zhang S, Du S, Sun M, Chen M, Zhong A, Wang X, Zhao Z, Zhou H, Li G, Ren Y, Luo Q, Yang A, Luo P, Tang S, Xu C, Wang Q, Wang X, Yan T, He W, Qin S, Zhang W, Lv L, Wang C, Liu H, Li J, Wu Q, Pan C, Li C, He L, Chen J. Pegmolesatide for the treatment of anemia in patients undergoing dialysis: a randomized clinical trial. EClinicalMedicine. 2023 Oct 28;65:102273. doi: 10.1016/j.eclinm.2023.102273. eCollection 2023 Nov.