Efficacy of Lanthanum Carbonate in Calciphylaxis

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01289626
First received: February 2, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Calciphylaxis
Drug: lanthanum carbonate
Drug: Lanthanum for calciphylaxis
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: February 2011
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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®

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01289626

Locations
United States, Wisconsin
University of Wisconsin Hospitals
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Shire
Investigators
Principal Investigator: Micah Chan, MD MPH University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01289626     History of Changes
Other Study ID Numbers: H-2010-0127
Study First Received: February 2, 2011
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Calciphylaxis, dialysis

Additional relevant MeSH terms:
Calciphylaxis
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014