A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis
NCT ID: NCT00646035
Last Updated: 2008-03-28
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
PHASE3
75 participants
INTERVENTIONAL
2002-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
paricalcitol capsules
baseline iPTH/60
B
paricalcitol capsules
baseline iPTH/60
Interventions
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paricalcitol capsules
baseline iPTH/60
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is diagnosed with ESRD and must be on continuous PD 7 days per week for at least 2 months prior to Screening Phase.
* If female, subject is either not of childbearing potential or is of childbearing potential and practicing one of the recommended methods of birth control.
* If female, subject must have a negative serum pregnancy test prior to treatment.
* If female, subject is not breastfeeding.
* Subject is undergoing full PD regimen and is expected to remain on this PD regimen for the duration of the study.
* For those subjects who have been taking a phosphate binder prior to therapy, the subject has been on a stable type of phosphate binder at least 4 weeks prior to the Pre-Treatment Phase.
* For entry into the Pretreatment Phase the subject must have: Calcium level less than or equal to 10.5 mg/dL and Ca x P level less than or equal to 65.
* For entry into the Treatment Phase the subject must have: iPTH greater than or equal to 300 pg/mL, calcium level of 8.0 to 10.5 mg/dL, inclusive, and Ca x P less than or equal to 65.
* Subject has voluntarily signed and dated an IRB approved informed consent.
Exclusion Criteria
* Subject has had active peritonitis within 1 month prior to screening phase.
* Subject has had more than one episode of peritonitis within 4 months prior to screening phase.
* Subject has received a partial parathyroidectomy within 1 year prior to screening phase.
* Subject has had acute renal failure within 3 months of screening phase.
* Subject has chronic gastrointestinal disease.
* Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the screening phase or will require these medications greater than 3 weeks in the study.
* Subject has a current malignancy or clinically significant liver disease.
* Subject has a history of drug or alcohol abuse within 6 months prior to screening phase.
* Subject has evidence of poor compliance with diet, medication, or PD.
* Subject has participated in any investigational drug or device study within 4 weeks prior to the treatment phase.
* Subject is taking maintenance calcitonin, glucocorticoids, or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
* For any reason, subject is considered by the investigator to be an unsuitable candidate to receive paricalcitol capsules.
* Subject is known to be HIV positive.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Los Angeles, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Tampa, Florida, United States
Savannah, Georgia, United States
Evanston, Illinois, United States
Maywood, Illinois, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Mineola, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Lubbock, Texas, United States
Krakow, , Poland
Krakow, , Poland
Countries
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Other Identifiers
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R&D/02/655
Identifier Type: -
Identifier Source: secondary_id
2001-015
Identifier Type: -
Identifier Source: org_study_id