Daprodustat increases hemoglobin and quality of life in patients with CKD
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Compared with placebo, daprodustat was well tolerated and significantly increased hemoglobin levels in patients with chronic kidney disease, according to research presented at ASN Kidney Week.
In addition, the hypoxia-inducible factor prolyl hydroxylase inhibitor also led patients to report higher quality of life Vitality scores during a period of 28 weeks.
"In patients with anemia of CKD not receiving dialysis, a double-blind placebo-controlled trial showed that daprodustat increased hemoglobin and decreased fatigue over a 28-week period without affecting overall rates of adverse events," said Kristen L. Johansen, MD, director of nephrology at Hennepin Healthcare at the University of Minnesota, during an oral abstract session.
The most common adverse events included diarrhea, hypertension and peripheral edema, which "didn't differ substantially between the groups," Johansen said.
The primary endpoint was the mean change in hemoglobin from baseline, with secondary endpoints including the ratio of patients who had at least a1 g/dL increase in hemoglobin and change in quality of life scores based on the Vitality scale, which reports on energy and fatigue, Johansen said.
A total of 614 adults with stage 3 or higher CKD and who were not on dialysis were randomized into either the daprodustat or placebo groups.
A total of 235 patients, or 77% of participants, in the daprodustat arm experienced an increase in hemoglobin of at least 1 g/dL compared with 54 patients, or 18%, in the placebo group, according to Johansen.
Patients who received daprodustat had a quality of life score increase of 7.29 points compared with an average score increase of 1.93 points in the placebo group.
A prior phase 2 trial found that compared with an injectable erythropoiesis-stimulating agent, oral daprodustat increased hemoglobin.
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Johansen KL, et al. Abstract FR-OR53. Presented at: ASN Kidney Week; Nov. 2-7, 2021 (virtual meeting).
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