CalciphylaxisPhase 1NCT01289626
Efficacy of Lanthanum Carbonate in Calciphylaxis
A Phase 1 study testing lanthanum carbonate and Lanthanum for calciphylaxis in people with Calciphylaxis, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calciphylaxis
- What is being tested?
- lanthanum carbonate and Lanthanum for calciphylaxis
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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®
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospitals
Madison, Wisconsin, 53705
About this study
Official title: 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.
Read the 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
- Being tested
- lanthanum carbonate, Lanthanum for calciphylaxis
- Keywords
- Calciphylaxis, dialysis
- Medical subject headings
- Calciphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lanthanum carbonateDrug
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.
Lanthanum for calciphylaxisDrug
Lanthanum use in calciphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
Intact PTH
Secondary aim will be the control of laboratory parameters of intact PTH
Measured: 12 weeks
Albumin
Secondary aim will be the control of laboratory parameters of albumin
Measured: 12 weeks
Quality of life
Demonstration of improved DLQI (Dermatology Life Quality Index, http://www.dermatology.org.uk/quality/quality-dlqi-questionnaire.html) scores
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalciphylaxisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- Micah Chan, MD MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289626
- Sponsor's protocol ID
- H-2010-0127
- Status last verified
- May 2014
- First submitted
- 2 Feb 2011
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Lanthanum Carbonate (Fosrenol) in Patients With Calciphylaxis
- ClinicalTrials.gov ID
- NCT01289626
- Acronym / sponsor ID
- H-2010-0127
- Conditions
- Calciphylaxis
- Keywords
- Calciphylaxis, dialysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lanthanum carbonateFOSRENOL® 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 calciphylaxisLanthanum use in calciphylaxis | Drug | – |
Primary outcome
Remission of calciphylaxis skin lesions
Time frame: 12 weeks
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.
4 secondary outcomes
Measurement of phosphorus
Time frame: 12 weeks
Intact PTH
Time frame: 12 weeks
Albumin
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micah Chan, MD MPH principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lanthanum carbonate and Lanthanum for calciphylaxis in people with Calciphylaxis, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of calciphylaxis skin lesions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2014.