Efficacy of Lanthanum Carbonate in Calciphylaxis
关键词
抽象
描述
Calciphylaxis or calcific uremic arteriolopathy is an infrequently occurring although debilitating vasculopathy seen primarily in patients with end stage renal disease (ESRD) which almost always affects the skin. It has a prevalence rate ~4 % in long term hemodialysis patients, with 1-year survival of 45% and an 8-fold risk of death as compared to the general dialysis population. (Surgery 1997;122:1083-1089, Kidney Int 2001;60:324-332). Despite being described in the literature for over 100 years, there has been no proven effective therapy. Lanthanum carbonate (FOSRENOL®) is a potent non-aluminum, non-calcium phosphate binder that was approved for use to reduce serum phosphate levels in patients with end stage renal disease. Since the proposed etiologic mechanism of injury and vascular calcification of calciphylaxis is predominantly hyperphosphatemia, elevated serum PTH, and hypercalcemia, FOSRENOL® would be an ideal pharmacologic agent to utilize in this extremely enigmatic disease (Dermatol Clin. 2008 Oct;26(4):557-68). Furthermore, a recent case report demonstrated a significant improvement in laboratory parameters and calciphylaxis skin lesions with the use of FOSRENOL® (WMJ. 2008 Nov;107(7):335-8). The primary hypothesis is that since calciphylaxis represents the ultimate sequelae of metastatic vascular calcification predominantly involving hyperphosphatemia, elevated serum PTH, and hypercalcemia, FOSRENOL® will be efficacious in its treatment.
日期
最后验证: | 04/30/2014 |
首次提交: | 02/01/2011 |
提交的预估入学人数: | 02/02/2011 |
首次发布: | 02/03/2011 |
上次提交的更新: | 05/18/2014 |
最近更新发布: | 05/19/2014 |
实际学习开始日期: | 01/31/2011 |
预计主要完成日期: | 02/28/2013 |
预计完成日期: | 04/30/2013 |
状况或疾病
干预/治疗
Drug: lanthanum carbonate
Drug: Lanthanum for calciphylaxis
相
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - i Participants will have signed a witnessed informed consent. ii Participants will be greater than or equal to 18 years of age iii Chronic renal failure receiving hemodialysis or peritoneal dialysis iv A diagnosis of calciphylaxis proven by skin biopsy or initial dermatology visit within the previous 5 year v Serum phosphorus > 4.5 mg/dL Exclusion Criteria: - i Participants are not able to understand or provide written informed consent ii The research team deems that the participant may not be able to follow the study protocol. iii Non-dependent HD patients receiving dialysis while in acute kidney injury; iv Pregnant dialysis patient v Active gastrointestinal obstruction or bleed vi Active inflammatory bowel disease vii Acute arteriovenous graft occlusion viii Known hypersensitivity to FOSRENOL® |
结果
主要结果指标
1. Remission of calciphylaxis skin lesions [12 weeks]
次要成果指标
1. Measurement of phosphorus [12 weeks]
2. Intact PTH [12 weeks]
3. Albumin [12 weeks]
4. Quality of life [12 weeks]