‘Many unanswered questions’ remain in CKD anemia management
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Research investigating the mechanisms of anemia in patients with chronic kidney disease, as well as optimal management strategies, is ongoing, according to a speaker at the Annual Dialysis Conference.
Guidelines for treatment of anemia in patients with CKD were last updated in 2012, “but it’s clear that we will need new guidelines,” Jodie L. Babitt, MD, an associate professor of medicine at Massachusetts General Hospital and Harvard Medical School, said during the presentation.
Since 2012, there have been updates in research, “the most important of which is the PIVOTAL trial,” Babitt said.
The prospective, noninferiority randomized controlled trial compared a “proactive strategy” in which patients received 400 mg per month of IV iron, unless patients’ transferrin saturations were greater than 40% or ferratin was above 700 g/L, with a “reactive strategy” in which patients received a lower dose of iron only when their transferrin saturations were less than 20% or ferratin was less than 200 g/L, according to Babitt.
The PIVOTAL trial’s primary outcome measure was a composite of time to first nonfatal myocardial infarction, stroke, heart failure hospitalization or death, according to data presented by Babitt. She said “there was a small but significant improvement” to this endpoint.
To address the findings that have been published since the current guidelines were issued, KDIGO has begun updating guidelines, which Babitt said “will play out over the next few years.”
However, many unknowns remain. For example, after the PIVOTAL trial, “it still remains unknown whether lower or intermediate dose or target strategies might have been sufficient, and we still don’t know the upper limit of [transferrin saturation] T-SAT or ferratin in terms of safety, [erythropoiesis-stimulating agent] ESA dose reduction or patient outcomes,” Babitt said.
There are limitations across studies investigating this area, according to Babitt, who said, “the number of patients in these studies is relatively few. The amount of time in the study is relatively low, and many of these studies actually used no comparator or placebo rather than active comparison with ESAs.”
Furthermore, she added, “it’s still too early to really say how these agents are impacting iron parameters and the need for iron therapy.”
While research in this area is ongoing, a second controversies conference on novel immunotherapies is scheduled for the end of the year, according to Babitt.
“A lot has changed since 2012. We have new [randomized clinical trials] RCTs and other clinical trials; we have new therapeutic agents and biologic insights,” Babitt said. “There are still, however, many unanswered questions and more research is needed.”
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Babitt JL. Controversies in optimal iron use for CKD anemia management: Snapshot of a 2019 KDIGO Conference. Presented at: The Annual Dialysis Conference. March 5-7, 2021 (virtual meeting).
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