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Alkaline Phosphatase for treatment of Acute Renal Failure

Hospital-acquired Acute Renal Failure (ARF) occurs in as many as 4% of hospital admissions and 20% of critical care admissions. The incidence is increasing because of an aging population, the increasing exposure to nephrotoxic drugs in hospitals, and increasing number of surgical interventions.
Depending on the severity of renal failure, the mortality rate ranges from 7 percent to as high as 80 percent. Annually around 700,000 patients die of Acute Renal Failure in Europe, US and Japan. Currently the only treatment options are dialysis and kidney replacement. No drugs are approved to treat this condition.

Clinical trial
Sixteen patients (11active, 5 placebo) with Acute Renal Failure were treated for 24 hours as part of a double-blind, randomized, placebo-controlled for Alkaline Phosphatase in a Phase IIa study in 36 Sepsis patients. The study took place at the Department of Intensive Care Medicine of the Radboud University Medical Centre, Nijmegen, The Netherlands.

Results
The mortality in renal failure patients that received placebo treatment was found significantly higher (60%) than those who received AP (27%) (see Figure). This correlated with the decreased need for dialysis to treat Acute Renal Failure from 80% in the placebo group to 36% in the group treated with AP. Renal failure was defined “at entry” as serum creatinine >150µmol/L (or rapidly deteriorating serum levels within 24h of entry that included a value above 150µmol/L) or patients who were already receiving renal replacement therapy at entry.

Figure 1: The percentage mortality in sepsis patients with ARF that received either placebo or AP.

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Alkaline Phosphatase for treatment of sepsis and acute renal failure (262 KB)

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