NCT01289626

Efficacy of Lanthanum Carbonate in Calciphylaxis

Evaluation of Efficacy of Lanthanum Carbonate (Fosrenol) in Patients With Calciphylaxis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Calciphylaxis

Interventions

Type	Name	Description
DRUG	lanthanum carbonate	FOSRENOL® will be administered orally in a dose of 1500- 3750 mg daily in divided doses with meals. Dose escalation will be utilized to a target dose of 3750 mg daily or as designated by clinician over a 4-week period from start of study. The drug will be administered for 12 weeks.
DRUG	Lanthanum for calciphylaxis	Lanthanum use in calciphylaxis

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2011-02-04
• Last updated: 2014-05-20

Locations

1 site across 1 country: United States