Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)
NCT ID: NCT00792857
Last Updated: 2014-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2008-11-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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CTAP201 Injection at dose a
CTAP201 at dose a
CTAP201 Injection
Comparison of different dose strengths of CTAP201 after single dose.
CTAP201 Injection
CTAP201 at dose b or dose c
CTAP201 Injection
Comparison of different dose strengths of CTAP201 after single dose.
Doxercalciferol at dose a
Active at dose a
Doxercalciferol
Comparison of different dose strengths of doxercalciferol after single dose.
Doxercalciferol
Active at dose b or dose c
Doxercalciferol
Comparison of different dose strengths of doxercalciferol after single dose.
Interventions
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CTAP201 Injection
Comparison of different dose strengths of CTAP201 after single dose.
Doxercalciferol
Comparison of different dose strengths of doxercalciferol after single dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On maintenance hemodialysis three times per week
* Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL
* Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL
* Visit 1: Serum phosphorus value greater than or equal to 2.5 mg/dL and lower than or equal to 5.5 mg/dL
* Serum 25-hydroxyvitamin D level greater than or equal to 15 ng/mL
* Visit 2: Serum iPTH value greater than 300 pg/mL
* Visit 2: Serum Ca x P product less than 56 \[mg/dl\]2
* Willing and able to discontinue vitamin D and/or bone metabolism therapy for at least 2 weeks prior to administration of Study Drug, and length of study
Exclusion Criteria
* Abnormal liver functions
18 Years
80 Years
ALL
No
Sponsors
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OPKO IP Holdings II, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Melnick, MD
Role: STUDY_DIRECTOR
OPKO Renal
Locations
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Pivotal Reseach Centers
Peoria, Arizona, United States
Western New England Renal and Transplant Associates
Springfield, Massachusetts, United States
University of Cincinnati
Cincinnati, Ohio, United States
Northeast Clinical Research
Allentown, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
Southwest Houston Research Ltd.
Houston, Texas, United States
Countries
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Other Identifiers
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CTAP201-CL-1007
Identifier Type: -
Identifier Source: org_study_id
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