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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

NCT01134315 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2013-08-13

Study results available
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Summary

The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).

Conditions

  • Secondary Hyperparathyroidism
  • End-Stage Renal Disease

Interventions

DRUG

Paricalcitol

DRUG

Calcitriol

Sponsors & Collaborators

  • North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)

    collaborator UNKNOWN

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Ann Eldred, MD · AbbVie

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134315 on ClinicalTrials.gov