PEGMOLESATIDE FOR THE TREATMENT OF ANEMIA IN NON-DIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE PATIENTS: POST-HOC ANALYSIS OF A PHASE 3 TRIAL

Introduction:

Pegmolesatide, a novel long-acting pegylated erythropoietin mimetic peptide (EMP), demonstrated comparable efficacy and safety to epoetin alfa in a randomized, multicenter, open-label, non-inferiority phase 3 trial (NCT03903809). This post-hoc analysis aimed to explore further benefits of pegmolesatide in non-dialysis-dependent chronic kidney disease (NDD-CKD) patients with anemia.

Methods:

A total of 175 NDD-CKD patients without erythropoiesis-stimulating treatment were randomized (2:1) to receive pegmolesatide or epoetin alfa for 52 weeks. This post-hoc analysis included subgroup assessments of hemoglobin (Hb) level change from baseline to evaluation period, as well as evaluation of iron therapy, serum ferritin (SF) and transferrin saturation (TSAT).

Results:

Pegmolesatide resulted in a greater increase in Hb from baseline to evaluation period compared to epoetin alfa (P=0.0163, Figure 1). Better efficacy was observed in patients ≥65 years old, with baseline eGFR <15 mL/min/1.73 m2 or SF <200 ng/mL. Numerically less patients in pegmolesatide group required iron therapy (41.7% vs. 56.9%), or folic acid and vitamin B12 (24.3% vs. 29.3%) compared to epoetin alfa group. Those who received pegmolesatide were more likely to have a smaller reduction in SF and TSAT over 52 weeks (Figure 2).

Conclusions:

Pegmolesatide is non-inferior in increasing Hb level compared to epoetin alfa, and may optimize iron supplements and utilizations in NDD-CKD patients.

I have no potential conflict of interest to disclose.

I did not use generative AI and AI-assisted technologies in the writing process.