alpha-Melanocyte Stimulating Hormone Analogue AP214 Protects Against Ischemia Induced Acute Kidney Injury in a Porcine Surgical Model

Purpose: alpha-Melanocyte stimulating hormone protects kidneys against ischemia and sepsis induced acute kidney injury in rodents. We examined the efficacy of a-melanocyte stimulating hormone analogue AP214 to protect against acute kidney injury in higher vertebrates. Materials and Methods: We performed a prospective, blinded, randomized, placebo controlled study in 26 pigs. Laparoscopic technique was used for left nephrectomy and to induce complete warm ischemia in the right kidney for 120 minutes. AP214 (200 mu g/kg intravenously) was administered daily on the day of surgery and for 5 days thereafter. Kidney function was measured for 9 days. We measured changes in serum creatinine, estimated glomerular filtration rate, serum C-reactive protein and urine interleukin-18. Results: In the placebo control and AP214 groups mean peak serum creatinine was 10.2 vs 3.92 mg/dl and the estimated glomerular filtration rate nadir was 22.9 vs 62.6 ml per minute per kg (each p = 0.001). Functional nadir occurred at 72 vs 24 hours in the control vs AP214 groups. Estimated glomerular filtration rate outcome on postoperative day 9 was 118 vs 156 ml per minute per kg in the control vs AP214 groups (p = 0.04). Conclusions: We noted a robust renoprotective effect of AP214. A similar AP214 effect may be observed in humans. Future research includes mechanistic studies in pigs and a phase II human clinical trial of AP214 in kidney transplant and partial nephrectomy populations

Guidance for Product Category Rule Development

This guidance document is a response to an internationally recognized need for additional instruction on the development of rules specific to a category of products for making claims based on a life cycle assessment (LCA). The purpose is to supplement existing standards for LCA-based claims that require the development of product category rules (PCRs) or their equivalents. The aim is that PCRs can be developed in a consistent manner and used to support claims based on multiple standards. The scope of the Guidance is global. The Guidance embodies the efforts of individuals with expertise in LCA and LCA-based product claims from more over 40 organizations in 13 countries and regions under the name of The Product Category Rule Guidance Development Initiative. The Initiative received no financial support from any standard or other product claim program and this Guidance reflects no bias toward any particular standard or program. The Guidance is intended to be a living document and we hope that it will continue to improve as the application of product claims based on LCA expands and diversifies.JRC.H.8-Sustainability Assessmen