ArticleDrug design, development and therapy2026
Switching to Pegmolesatide in Maintenance Dialysis: Real-World Hemoglobin Response, Temporal Dynamics, and Modality-Specific Predictors.
Article in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Purpose: Pegmolesatide is a monthly subcutaneous erythropoietin mimetic peptide for renal anemia, but real-world data beyond randomized trials remain scarce. We evaluated its effectiveness, temporal response dynamics, and modality-specific response predictors in maintenance dialysis patients switched from prior anemia therapy. Patients and Methods: In this single-center retrospective study, 192 maintenance dialysis patients (hemodialysis [HD], n = 90; peritoneal dialysis [PD], n = 102) receiving monthly subcutaneous pegmolesatide were analyzed; 52.6% had switched from erythropoiesis-stimulating agents and 47.4% from a hypoxia-inducible factor prolyl hydroxylase inhibitor, predominantly for suboptimal anemia control. The primary endpoint was hemoglobin (Hb) change at month 3. Secondary endpoints included iron dynamics, mixed-effects modeling of temporal patterns (1,423 observations), and predictors of poor response. Results: Mean Hb increased from 96.4 ± 15.9 to 110.0 ± 19.2 g/L at month 3 (model-estimated Δ = +13.0 g/L; 95% CI, 9.8 to 16.3; P<0.001) and remained stable through month 12. Target achievement (Hb ≥ 110 g/L) rose from 19.8% to 54.5%. The Hb trajectory was nonlinear, with a rapid first-month rise followed by deceleration; increments were attenuated at higher baseline Hb (ceiling effect), and higher serum albumin was associated with faster Hb improvement. Iron deficiency declined from 46.3% at baseline to a model-estimated 20.4% at month 12. Higher baseline Hb predicted a smaller increment; dialysis vintage of 12-36 months independently predicted attenuated response (pooled OR 5.17-8.68; P<0.001). Predictors differed by modality (body mass index in HD; diabetes in PD). Thromboembolic events (2.6%) were exclusively vascular access-related; mortality was 2.1%. Conclusion: Monthly pegmolesatide was associated with rapid and sustained Hb improvement and acceptable safety. Baseline Hb and dialysis vintage were the dominant response predictors, with distinct modality-specific profiles, supporting evaluation of individualized dosing strategies in randomized trials.
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