Efficacy of Lanthanum Carbonate in Calciphylaxis

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

Study Overview

• Status: Completed
• Conditions: Calciphylaxis
• Intervention / Treatment: Drug: lanthanum carbonate; Drug: Lanthanum for calciphylaxis

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission of calciphylaxis skin lesions	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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of phosphorus	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.	12 weeks
Intact PTH	Secondary aim will be the control of laboratory parameters of intact PTH	12 weeks
Albumin	Secondary aim will be the control of laboratory parameters of albumin	12 weeks
Quality of life	Demonstration of improved DLQI (Dermatology Life Quality Index, http://www.dermatology.org.uk/quality/quality-dlqi-questionnaire.html) scores	12 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Shire
• Investigators: Principal Investigator: Micah Chan, MD MPH, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Calciphylaxis, dialysis
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis; Calciphylaxis
• Other Study ID Numbers: H-2010-0127