Human recombinant alkaline phosphatase did not significantly improve short-term kidney function when compared with placebo for the treatment of patients with sepsis-associated acute kidney injury, according to recently published findings.
“There are a number of explanations for this finding, the first of which is that this medication is not an effective treatment for sepsis-associated AKI,” Peter Pickkers, MD, PhD, and colleagues wrote. “However, there are alternative possible explanations including, second, that creatinine and its clearance are recognized to be of limited precision to estimate kidney function, especially during non-steady state conditions; however, a suitable clinical alternative is currently not available.”
The researchers noted several additional possibilities behind the ineffectiveness of the intervention, including the short length of the 7-day timeframe and a slight imbalance in kidney function between groups.
There were 301 patients enrolled in the study and were eligible if they had been admitted to the ICU, received a diagnosis of sepsis and acute kidney injury, were aged 18 to 85 years and were not expected to have a rapidly fatal outcome.
From day 1 to day 7, median extracorporeal circuit increased from 26 mL/min to 65.4 mL/min in the group that received 1.6 mg/kg of recombinant alkaline phosphatase vs. 35.9 mL/min to 61.9 mL/min in the placebo group.
Pickkers and colleagues reported adverse effects most patients, independent of treatment with recombinant alkaline phosphatase or placebo. Fatal serious adverse events occurred in 17.4% of patients treated with recombinant alkaline phosphatase and in 29.5% of patients in the placebo group.
“Longer-term exploratory kidney end points indicated that recombinant alkaline phosphatase resulted in more complete long-term recovery of kidney function compared with placebo,” the researchers wrote. “Although these beneficial effects are more patient-centered and clinically relevant, it is important to emphasize that these were exploratory end points of this study, so effects of recombinant alkaline phosphatase on longer-term kidney function and survival should be interpreted as only hypothesis-generating.” – by Joe Gramigna
Disclosures: The researchers report funding from AM-Pharma. Pickkers reported receiving travel reimbursements and fees for medical monitoring of this trial from AM-Pharma. Please see the study for all other authors’ relevant financial disclosures.