#686 The impact of Ferric Derisomaltose (FDI) on role physical functioning in iron deficient but not anaemic patients with chronic kidney disease
Authors: Bhandari Sunil , Jafri Alisha , Youlden Charlotte 
Published: May 2024

Abstract

Background and Aims
Chronic kidney disease (CKD) is a progressive disorder affecting physiological function, specifically iron deficiency. Iron is crucial for red blood cell production, oxygen transport, mitochondrial function, and cardiac function. Iron deficiency in patients with CKD results from decreased absorption and mobilization, which leads to anaemia, reduced functional capacity, increased cardiac risk, and poorer quality of life. The Iron and the Heart Trial investigated whether correcting iron deficiency in CKD patients (using a single dose of 1000 mg of intravenous (IV) ferric derisomaltose (FDI)) improved functional capacity, as measured by the six-minute walk test, and health-related quality of life (HRQoL) outcomes, including Physical and Mental Health. The SF-36v2 Health Survey tool was used to quantify HRQoL outcomes.
Patients identify that whilst clinical outcomes such as survival and functional capacity are important; HRQoL and the symptoms associated with disease burden are far more debilitating. Currently research on how Role Physical functioning, which assesses limitations in routine activities, affects QoL in people with CKD and iron deficiency is limited. This study aimed to explore if correcting iron deficiency in people with CKD without anaemia using IV FDI, improved Role Physical outcomes compared to a placebo group post-infusion at 3 months from the Iron and Heart Trial.

Method
The Iron and the Heart Trial was a multicentre double blinded randomised study in which non-anaemic CKD patients with iron deficiency were given 1000 mg of IV iron (FDI), compared to a placebo infusion at baseline, and assessed at 1 month and 3-months post-infusion, to evaluate the impact on exercise capacity. Secondary objectives of the trial included impact of iron therapy on QoL. This analysis focused on “Role Physical” as a QoL parameter in the trial participants. A total of 54 CKD patients with iron deficiency but no anaemia (Group 1) were enrolled in the trial and randomly assigned in a 1:1 ratio to either the FDI or placebo group. Within the 54 patients, 26 patients received FDI, and 28 patients received placebo. 10 CKD patients without anaemia or iron deficiency (Group 2) were also included, they did not receive any treatment and were followed up at the same time points as Group 1. Each group completed the Role Physical parameter of the SF-36v2 survey which assessed if participants had cut down the amount of time spent on activities, accomplished less, were limited, or performed tasks with more difficulty because of their condition. The collected responses were categorical variables that were summarised using number (%) and then normalised and summarised using mean (standard deviations). All analyses were undertaken using Microsoft Excel.

Results
At baseline the Role Physical means (SD) were as follows: placebo 42.8 ± 11.9, FDI 42.1 ± 11.0, Group 2 45.9 ± 9.4. Prior to any intervention, mean Role Physical outcomes were numerically poorer in those with CKD and iron deficiency (placebo and FDI) compared to those with CKD and no iron deficiency (Group 2) (Fig. 1a). Following intervention at 3 months the mean (SD) scores for each group were—placebo 37.5 ± 14.6, FDI 40.9 ± 11.4, Group 2 44.0 ± 13.2. The placebo group experienced a decrease of 12.3% in the mean score for Role Physical outcomes in comparison to their baseline whilst, FDI group only experienced a 3% decrease. For Group 2, there was a decrease of 4% from baseline to 3 months (Fig. 1b).

Conclusion
Our study showed that while FDI may not improve QoL outcomes, Role Physical functioning, in individuals with CKD and iron deficiency, it may still play a role in slowing the deterioration of these outcomes. Caution must be exercised when interpreting our findings due to the limitations of our study, and further research with sufficient power is needed to extend the findings of the study with a larger sample size to be able to make treatment recommendations for individuals with CKD and iron deficiency.