AM-Pharma announces positive results from its Acute Kidney Injury trial
Positive Phase II trial results confirm observations from earlier Acute Kidney Injury trial
AM-Pharma B.V. announced positive results from its Phase II acute kidney injury trial with Alkaline Phosphatase. AM-Pharma showed statistically significant improvement on the primary clinical endpoint and on several secondary endpoints after interim analysis of the treatment effect on 26 patients.
The primary objective of the trial was to show improved kidney function in Acute Kidney Injury patients treated with bovine Alkaline Phosphatase, measured by reduced serum creatinine, the standard indicator of kidney function. In patients treated with the drug, serum creatinine reduced faster over a 28 day period, compared to patients receiving placebo. The results are both statistically significant and clinically relevant.
Statistical significant improvement was also reached on several secondary endpoints. Average stay in Intensive Care and in hospital was much shorter for patients on Alkaline Phosphatase compared to patients on placebo. Also, SOFA scores, a measure of the function of six vital organ systems, which is correlated to survival of patients, improved significantly. Positive trends and clinically relevant treatment effects were observed in creatinine clearance and in reduction of dialysis requirement. The treatment was very well tolerated and there were no safety concerns.
In this double blind, placebo controlled, prospective clinical study in patients with Acute Kidney Injury secondary to sepsis, patients received Alkaline Phosphatase intravenously for 48 hours. The trial was conducted at critical care units in The Netherlands and Belgium. The full results will be presented in March 2010, at ISICEM in Brussels, one of the world’s leading Intensive Care conferences.
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