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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 October 2012 |
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Main ID: |
NCT01011114 |
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Date of registration:
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09/11/2009 |
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Primary sponsor: |
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Public title:
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Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant
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Scientific title:
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Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01011114 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Maria Coco, MD,MS |
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Address:
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Telephone:
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718-920-4136 |
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Email:
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mcoco@montefiore.org |
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Affiliation:
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Name:
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Maria Coco, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Montefiore Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- renal transplant within last 3 months
- serum phosphorus less than 2.0 mg/dl
- serum creatinine less than 2.0 mg/dl
Exclusion Criteria:
- sensitivity to cinacalcet
- use of amitryptiline, desipramine, itraconazole, ketoconazole
- pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypophosphatemia
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Renal Transplant
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Intervention(s)
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Drug: Cinacalcet
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Drug: Placebo
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Primary Outcome(s)
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improvement in serum phosphorus
[Time Frame: 3 months]
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Secondary ID(s)
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09-07-203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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