Acute kidney injury (AKI) is characterized by a sudden deterioration in kidney function that disrupts metabolic, electrolyte, and fluid homeostasis. According to Decision Resources Group’s (DRG) survey of U.S. nephrologists and critical care physicians, one of the more common causes of this disease is sepsis, accounting for 25% - 39% of all AKI patients seen in the past year. 1 Other common causes include severe heart disease, nephrotoxic medications, urinary track obstruction, and glomerulonephritis (see Figure 1). AKI is consistently associated with poor outcomes for patients including mortality. In patients with sepsis, incidence of AKI can range from 9% to 51%, with 6% to 11% requiring dialysis. The in-hospital mortality rates can range from 69% to 74%.2

Figure 1: Causes of AKI



Depending on its severity, AKI may lead to various complications, including metabolic acidosis, hyperkalemia, uremia, and disturbance of fluid homeostasis. Surveyed physicians report that management of this condition can be a challenge and current treatment approaches are limited to fluid management, continuous veno-venous hemofiltration, intermittent hemodialysis, prednisone, sodium bi-carbonate, N-acetylcysteine and withdrawal of offending medications and toxins. 2 Physicians lament the need for specific treatment for treating AKI (see Figure 2).

Figure 2: Key Challenges in AKI Management



AM-Pharma has developed a human recombinant form of alkaline phosphatase (recAP), which generated positive results in a Phase II trial involving patients with AKI. The trial included over 300 patients with sepsis and AKI showed a 40% relative reduction in mortality compared with patients who received placebo. The significant improvements demonstrated in survival are impressive, plus recAP also demonstrated progressive and sustained improvement in renal function during the 28-day study period. Furthermore, there were no safety concerns throughout the study. However, it is important to note that the addition of recAP to the standard of care did not affect kidney function in the first week, which was the primary endpoint of the study.3

It is no surprise that the FDA has already granted fast track designation of recAP for the treatment of sepsis-associated AKI4 since it is an increasingly common and potentially catastrophic complication in hospitalized patients. AKI affects millions of patients each year,5 and with no specific treatments available, a therapy to treat AKI is eagerly awaited by physicians. Even though recAP did not achieve its primary end-point, it has finally given the nephrology community hope.

In-depth analysis of factors that drive and constrain AKI treatment, as well as treatment shares and line of therapy analysis, can be found in Decision Resources Group’s Current Treatment: Acute Kidney Injury (US) 2018 insights.

RELATED DRG CONTENT (FOR CLIENTS OR PURCHASE)
Acute Kidney Injury | Current Treatment | Detailed, Expanded Analysis

1Decision Resources Group’s CurrentTreatment: Acute Kidney Injury (US) content provides a deep dive into the “What” and the “Why” of current treatment practices and prescribing patterns for AKI. The report focuses on how patients are being treated today, and what are the key factors behind those treatment decisions. It examines the management of AKI patients from the perspective of 100 U.S. nephrologists and critical care physicians. This content is based on primary market research with expert analysis.

2Waikar S, Liu K, Chertow G.  Diagnosis, epidemiology and outcomes of acute kidney injury. Clin J Am Soc Nephrol 2008; 3: 844-861.

3https://www.am-pharma.com/blog/2018/03/am-pharma-announces-phase-ii-study-results-of-recap-in-sepsis-associated-acute-kidney-injury

4https://www.am-pharma.com/blog/2016/04/am-pharma-receives-fda-fast-track-designation-for-recap-in-acute-kidney-injury

5Rewa O and Bagshaw SM. Acute kidney injury-epidemiology, outcomes and economics. Nat Rev Nephrol 2014; 10:193-207.

 

 


Contributors: Jihan Khan, Ph.D : Principal Business Insights Analyst
Published on: 30 March, 2018