Roxadustat shows increases in Hb regardless of prior roxadustat use in CKD

Roxadustat treatment increased haemoglobin (Hb) levels in individuals with chronic kidney disease (CKD) who previously had roxadustat treatment or were naïve. Anaemic conditions were improved for patients regardless of dialysis status.

Anaemia is a prevalent condition for individuals with CKD, and is associated with poor quality of life and faster progression to end-stage kidney disease. Roxadustat is known to increase red blood cell production and affects iron metabolism. A phase 3 clinical trial showed that roxadustat increased Hb levels in individuals with CKD [1].

The current phase 4 trial was a multicentre, open-label, prospective study conducted at 61 institutions across China [2]. The primary endpoint was a safety analysis. Secondary endpoints included measures of Hb and quality of life (not presented in this session). The safety analysis was conducted on 2,021 patients; 193 had previously been treated with roxadustat, 1,804 were naïve. All participants received at least 1 additional dose of roxadustat. The study included a 70–120 mg oral dose of roxadustat 3 times a week for 52 weeks. In the roxadustat-naïve population, the mean ± SE Hb level at baseline was 96.94 ± 0.33 g/L.

In total, 10.8% of patients experienced drug-related treatment-emergent adverse events (TEAEs). The most common drug-related TEAEs were nausea (1.3%), hypertension (1.0%), and insomnia (0.9%). Roxadustat treatment led to increased Hb levels, with a peak at week 12. The difference from baseline over weeks 24–36 was 14.20 ± 0.38 g/L. The estimated percentage of patients with Hb ≥100 g/L was 83.3% between weeks 24–36. Increases in Hb were sustained regardless of dialysis status. In the group previously treated with roxadustat, moderate increases in Hb (around 10 g/L) were also observed and sustained.

1. Chen N, et al. N Engl J Med 2019; Sept 12. DOI: 10.1056/NEJMoa1813599.
2. Du X, et al. A National, Multi-Center, Prospective Study Evaluating the Long-Term Safety and Effectiveness of Roxadustat for Anemia Treatment in Patients with CKD (ROXSTAR Registry). TH-PO980, ASN Kidney Week 2023, 2–5 November, Philadelphia, PA, USA.

 

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Posted on 28 November, 202328 November, 2023