It appears you don't have support to open PDFs in this web browser. To view this file, Open with your PDF reader
Abstract
ABSTRACT
Background
Calcific uraemic arteriolopathy (CUA; calciphylaxis) is a rare disease seen predominantly in patients receiving dialysis. Calciphylaxis is characterized by poorly healing or non-healing wounds, and is associated with mortality, substantial morbidity related to infection and typically severe pain. In an open-label Phase 2 clinical trial, SNF472, a selective inhibitor of vascular calcification, was well-tolerated and associated with improvement in wound healing, reduction of wound-related pain and improvement in wound-related quality of life (QoL). Those results informed the design of the CALCIPHYX trial, an ongoing, randomized, placebo-controlled, Phase 3 trial of SNF472 for treatment of calciphylaxis.
Methods
In CALCIPHYX, 66 patients receiving haemodialysis who have an ulcerated calciphylaxis lesion will be randomized 1:1 to double-blind SNF472 (7 mg/kg intravenously) or placebo three times weekly for 12 weeks (Part 1), then receive open-label SNF472 for 12 weeks (Part 2). All patients will receive stable background care, which may include pain medications and sodium thiosulphate, in accordance with the clinical practices of each site. A statistically significant difference between the SNF472 and placebo groups for improvement of either primary endpoint at Week 12 will demonstrate efficacy of SNF472: change in Bates-Jensen Wound Assessment Tool-CUA (a quantitative wound assessment tool for evaluating calciphylaxis lesions) or change in pain visual analogue scale score. Additional endpoints will address wound-related QoL, qualitative changes in wounds, wound size, analgesic use and safety.
Conclusions
This randomized, placebo-controlled Phase 3 clinical trial will examine the efficacy and safety of SNF472 in patients who have ulcerated calciphylaxis lesions. Patient recruitment is ongoing.
You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer
Neither ProQuest nor its licensors make any representations or warranties with respect to the translations. The translations are automatically generated "AS IS" and "AS AVAILABLE" and are not retained in our systems. PROQUEST AND ITS LICENSORS SPECIFICALLY DISCLAIM ANY AND ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES FOR AVAILABILITY, ACCURACY, TIMELINESS, COMPLETENESS, NON-INFRINGMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Your use of the translations is subject to all use restrictions contained in your Electronic Products License Agreement and by using the translation functionality you agree to forgo any and all claims against ProQuest or its licensors for your use of the translation functionality and any output derived there from. Hide full disclaimer
Details
1 Renal Medicine, Salford Royal NHS Foundation Trust , Salford, UK
2 South Shore Health Department of Surgery, South Shore Health Center for Wound Healing , Weymouth, MA, USA
3 Department of Medicine, Massachusetts General Hospital , Boston, MA, USA
4 SerenaGroup Research Foundation , Cambridge, MA, USA
5 Cardiology and Nephrology, Rhein-Maas Hospital , Würselen, Germany
6 Department of Medicine, Indiana University School of Medicine , Indianapolis, IN, USA
7 Clinical Affairs, DaVita Kidney Care , Naples, FL, USA
8 Fresenius Kidney Care , Waltham, MA, USA
9 Global Head of Clinical Affairs, Fresenius Kidney Care , Waltham, MA, USA
10 Department of Clinical Development, Sanifit Therapeutics , San Diego, CA, USA
11 KJC Statistics Ltd , Cheshire, UK
12 University Institute of Health Sciences Research (IUNICS- IDISBA), University of the Balearic Islands , Palma, Spain
13 Department of Medicine, Stanford University School of Medicine , Stanford, CA, USA