A PROSPECTIVE, SINGLE-CENTRE STUDY ON THE EFFICACY AND SAFETY OF DESIDUSTAT IN CHRONIC KIDNEY DISEASE-INDUCED ANEMIA

Introduction:

Anemia in Chronic Kidney Disease (CKD) is a multifactorial disorder primarily treated with erythropoietin (EpO) analogs. Desidustat, a novel Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI), offers a convenient oral alternative to subcutaneous EpO injections for treating anemia in both dialysis-dependent and non-dialysis CKD (ND-CKD) patients. This study aims to prospectively evaluate the efficacy and safety of Desidustat in patients with CKD-induced anemia.

Methods:

This prospective, single-center, observational study enrolled patients diagnosed with CKD anemia between January 2023 till December 2023. Baseline assessment of iron status was mandatory. Patients with %TSAT >20 and ferritin > 100ng/ml (ND-CKD, including post-transplant patients) and >200ng/ml (dialysis dependent CKD) were enrolled. Important exclusion criteria was severe uncontrolled hypertension at baseline requiring ≥ 3 antihypertensives with SBP >160 mmHg or DBP > 110 mmHg. All patients received Desidustat 100 mg thrice weekly. At each follow-up visit (3 monthly), haemoglobin (Hb) levels and adverse drug reactions were assessed. Dose modifications were applied based on Hb response.

Results:

A total of 120 patients were enrolled, with 70 completing three follow-ups. Of these 70 patients, 45 (64.2%) were male and 25 (35.7%) females, with a mean age of 54.2 ± 18.4 years. Most patients were in CKD stage 5 (25, 35.7%), followed by stage 4 (8,11%). Majority of the patients were suffering from T2DM (16,22.8%). Other diseases like IgA nephropathy (3, 4.2%), FSGS (2,2.8%), and ADPKD (2,2.8%). Eight patients had post-transplant anemia. All patients were treated with Desidustat 100 mg thrice weekly, resulting in a significant rise in Hb levels (p=0.005, one-way ANOVA). The mean absolute Hb increase from baseline was 1.15 g/dL. Out of 70 patients, 5 (7.14%) patients had Erythropoietin (ESA) hypo-responsiveness showed improvement with Desidustat. There were no significant changes in serum potassium levels, and no major adverse cardiovascular events were reported in our follow up. All patients demonstrated good compliance with therapy.

Conclusions:

Desidustat is a safe and effective oral therapy for the treatment of anemia in CKD patients, offering a viable alternative to traditional erythropoietin injections considering oral route of administration. Since it does not require strict cold chain it is particularly suitable for  tropical countires. Additionally, it may prove particularly efficacious in patients with ESA hypo-responsiveness. Caution needs to be exercised in excluding patients with severe uncontrolled hypertension at baseline

I have no potential conflict of interest to disclose.

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