View Clinical Trial (Medical Research Study)
Evaluation of Efficacy of Lanthanum Carbonate (Fosrenol) in Patients With Calciphylaxis
| City: |
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Madison |
| State: |
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Wisconsin |
| Zip Code: |
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53705 |
| Conditions: |
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Calciphylaxis |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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®
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| NCT ID: |
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NCT01289626 |
| Primary Contact: |
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Principal Investigator
Micah Chan, MD MPH
University of Wisconsin, Madison
Micah R Chan, MD MPH
Phone: 608-270-5656
Email: mr.chan@hosp.wisc.edu
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| Backup Contact: |
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Email: OShobande@uwhealth.org
Tokunbo Shobande, MD
Phone: 608-270-5656
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| Location Contact: |
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Madison, Wisconsin 53705
United States
Micah Chan, MD MPH
Phone: 608-270-5656
Email: mr.chan@hosp.wisc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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