Efficacy of Lanthanum Carbonate in Calciphylaxis
The research question and primary aim is to determine if lanthanum carbonate is effective in treating calciphylaxis by measurement of complete or partial remission of skin lesions. Secondary endpoints will be measured to determine if lanthanum carbonate can lower calcium-phosphorus product levels, intact PTH and mortality. Albumin levels will be measured as a marker of nutritional status and inflammation.
Drug: lanthanum carbonate
Drug: Lanthanum for calciphylaxis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Efficacy of Lanthanum Carbonate (Fosrenol) in Patients With Calciphylaxis|
- Remission of calciphylaxis skin lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The primary aim of this study will be the complete or partial remission of calciphylaxis skin lesions after 12 weeks of therapy as defined by the clinician.
- Measurement of phosphorus [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Improvement in phosphorous control (target concentrations of 3.5 - 5.5 mg/dL) will also be monitored to correlate the relationship between phosphorous levels and calciphylaxis.
- Intact PTH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Secondary aim will be the control of laboratory parameters of intact PTH
- Albumin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Secondary aim will be the control of laboratory parameters of albumin
- Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Demonstration of improved DLQI (Dermatology Life Quality Index, http://www.dermatology.org.uk/quality/quality-dlqi-questionnaire.html) scores
|Study Start Date:||February 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Drug: lanthanum carbonate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289626
|United States, Wisconsin|
|University of Wisconsin Hospitals|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Micah Chan, MD MPH||University of Wisconsin, Madison|