Results from the PIVOTAL trial were presented during the High-Impact Clinical Trials session at American Society of Nephrology (ASN) Kidney Week 2018
The trial met its primary endpoint of noninferiority as assessed by a composite of death and cardiovascular events, demonstrating that a liberal, proactive intravenous (IV) iron dosing regimen did not expose patients to an increased level of harm
Treatment with greater doses of iron, allowing for higher ferritin and transferrin saturation (TSAT) levels, was associated with significantly reduced rates of the primary outcome when the components were analysed as recurrent events and was less likely to result in hospitalisation for heart failure
Among patients on maintenance haemodialysis, a proactive, high-dose regimen of IV iron significantly reduced dose requirements for erythropoiesis-stimulating agents (ESAs) and the need for blood transfusions, without adversely impacting mortality or safety endpoints such as hospitalisation or infection
Across Europe and the United States, more than 70% of patients on maintenance haemodialysis receive IV iron1-4
- Bailie GR, Larkina M, Goodkin DA, et al. Variation in intravenous iron use internationally and over time: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant 2013;28:2570-2579.
- US-DOPPS (Dialysis Outcomes and Practice Patterns Study) Practice Monitor. IV iron use, last 3 months. April 2018; https://www.dopps.org
htm. Accessed October 10, 2018.
- Germany-DOPPS (Dialysis Outcomes and Practice Patterns Study) Practice Monitor. IV iron use, last 3 months. June 2016; https://www.dopps.org
Accessed October 10, 2018.
- Robinson BM, Larkina M, Bieber B, et al. Evaluating the effectiveness of IV iron dosing for anemia management in common clinical practice: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). BMC Nephrol 2017;18:330.
- Macdougall IC, White C, Anker SD, et al. Randomized trial comparing proactive, high-dose versus reactive, low-dose intravenous iron supplementation in hemodialysis (PIVOTAL): study design and baseline data. Am J Nephrol 2018;48:260-268.
- US-DOPPS (Dialysis Outcomes and Practice Patterns Study) Practice Monitor. Monthly IV iron dose received (90 day average), continuous (mg). April 2018; https://www.dopps.org/DPM/Files/sum_IVIRON90DAY_overallTAB.htm. Accessed October 10, 2018.
- US-DOPPS (Dialysis Outcomes and Practice Patterns Study) Practice Monitor. Serum ferritin (3 month average), continuous (ng/mL). April 2018; https://www.dopps.org/DPM/Files/meanferritinngml1_overallTAB.htm. Accessed October 10, 2018.
- Macdougall IC, Bircher AJ, Eckardt KU, et al. Iron management in chronic kidney disease: conclusions from a “Kidney Disease: Improving Global Outcomes” (KDIGO) Controversies Conference. Kidney Int 2016;89:28-39.
- World Health Organization. Preventing and controlling iron deficiency anaemia through primary health care. 1989; http://www.who.int/nutrition/publications/micronutrients/anaemia_iron_
deficiency/ida_preventng_control_primary_healthcare.pdf Accessed October 17, 2018.