Roxadustat safe and effective for treatment of anemia in CKD patients, finds study
Delhi: Roxadustat is equally effective as darbepoetin alfa (DA) for the treatment of anemia in patients with chronic kidney disease (CKD), according to a recent study in the journal Nephrology Dialysis Transplantation. According to the study, roxadustat was noninferior to DA in Hb levels correction during the treatment of the first 24 weeks in patients with CKD stages 3-5 not on dialysis (NDD).
The findings were also presented in an oral session at the European Renal Association-European Dialysis and Transplant Association 2020 virtual congress
Roxadustat is an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor for anemia treatment in patients with CKD. Jonathan Barratt, University of Leicester, Leicester, United Kingdom, and colleagues compared the efficacy and safety of roxadustat with DA for treatment of anemia in CKD patients NDD in this randomized, open-label, active-controlled phase 3 study.
Results from a protocol-specified interim analysis, performed after pts had either completed ≥36 weeks of treatment or had withdrawn from the study, were presented in the journal.
The study enrolled patients NDD CKD stages 3-5 and anemia (hemoglobin [Hb] ≤10.5 g/dL). They were randomized to receive roxadustat or DA. Following prescribed initial doses (weight-based), dose adjustments were permitted, with the goal of correcting and maintaining Hb. The primary endpoint was Hb response, defined as Hb ≥11.0 g/dL and a Hb increase from baseline (BL) of ≥1.0 g/dL in pts with BL Hb >8.0 g/dL, or an increase of ≥2.0 g/dL in pts with BL Hb ≤8.0 g/dL, during the first 24 weeks of treatment without rescue therapy.
The full analysis set (FAS) included pts who received ≥1 dose of study drug and had ≥1 post-dose Hb assessment. The per-protocol set (PPS) included FAS pts who did not meet the exclusion criteria. The safety analysis set (SAF) included pts who received ≥1 dose of study drug.
On 15 June 2018, 616 pts were randomised to receive roxadustat (n=323) or DA (n=293); of these 616 patients, 395 patients (roxadustat, n=194; DA, n=201) were still receiving treatment and 89 patients had completed ≥2 years of treatment (roxadustat, n=55; DA, n=34).
Key findings of the study include:
- In the PPS, 89.5% (n=256) of roxadustat pts responded in the first 24 weeks compared with 78.0% (n=213) of DA pts, for a difference of 11.51%, thereby establishing roxadustat's noninferiority to DA.
- The noninferiority of roxadustat to DA was also demonstrated for MAP and time to the occurrence of hypertension. In the FAS, the superiority of roxadustat to DA was demonstrated for low-density lipoprotein (LDL) and time to first IV iron use.
- In the SAF, the overall incidence of AEs was comparable between roxadustat and DA (85.8% and 84.6%, respectively).
"This analysis demonstrates that roxadustat was noninferior to DA in the correction of Hb levels during the first 24 weeks of treatment in pts with NDD CKD stages 3-5 and anemia. Safety profiles were comparable between groups," concluded the authors.
The study, ". Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis: A Phase 3, Randomised, Open-Label, Active-Controlled Study," is published in the journal Nephrology Dialysis Transplantation.