Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice
NCT ID: NCT01134315
Last Updated: 2013-08-13
Study Results
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View full resultsBasic Information
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TERMINATED
61 participants
OBSERVATIONAL
2010-06-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Paricalcitol
Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
Paricalcitol
Calcitriol
Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
Calcitriol
Interventions
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Paricalcitol
Calcitriol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level.
3. The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry.
4. Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.
5. Patient has received paricalcitol or calcitriol for a minimum of 10 days.
Exclusion Criteria
2. Patient is expected to stop peritoneal dialysis within 3 months.
3. Patient is expected to transfer to hemodialysis within 3 months.
4. Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.
16 Years
ALL
No
Sponsors
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North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
UNKNOWN
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Eldred, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 37082
Birmingham, Alabama, United States
Site Reference ID/Investigator# 26762
Gainesville, Florida, United States
Site Reference ID/Investigator# 28529
Orlando, Florida, United States
Site Reference ID/Investigator# 26748
Atlanta, Georgia, United States
Site Reference ID/Investigator# 37582
New Orleans, Louisiana, United States
Site Reference ID/Investigator# 39973
Baltimore, Maryland, United States
Site Reference ID/Investigator# 26769
Boston, Massachusetts, United States
Site Reference ID/Investigator# 26768
Detroit, Michigan, United States
Site Reference ID/Investigator# 26747
Kansas City, Missouri, United States
Site Reference ID/Investigator# 26749
Akron, Ohio, United States
Site Reference ID/Investigator# 26751
Cincinnati, Ohio, United States
Site Reference ID/Investigator# 26765
Columbus, Ohio, United States
Site Reference ID/Investigator# 28528
Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 26763
Portland, Oregon, United States
Site Reference ID/Investigator# 28526
Charlottesville, Virginia, United States
Site Reference ID/Investigator# 26758
Seattle, Washington, United States
Site Reference ID/Investigator# 40382
Madison, Wisconsin, United States
Site Reference ID/Investigator# 26759
Wauwatosa, Wisconsin, United States
Countries
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Related Links
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Related Info
Other Identifiers
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P12-053
Identifier Type: -
Identifier Source: org_study_id
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