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
This study has been terminated.
(Study stopped)
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01134315
First received: May 28, 2010
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
The objective of this study is to observe the safety of paricalcitol utilization in pediatric patients (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Patients will 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). Approximately 80 patients will be enrolled, 40 on paricalcitol and 40 on calcitriol.
| Condition | Intervention |
|---|---|
|
Secondary Hyperparathyroidism End-Stage Renal Disease |
Drug: Paricalcitol Drug: Calcitriol |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules as Determined by Hypercalcemia in Pediatric Patients Ages 0 to 16 With Chronic Kidney Disease (CKD) Stage 5 Receiving Peritoneal Dialysis (PD) Within Current Clinical Practice |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Hypercalcemia [ Time Frame: 3 to 36 months ] [ Designated as safety issue: Yes ]The incidence of hypercalcemia (calcium > 10.2 mg/dL)
Secondary Outcome Measures:
- Adverse Events [ Time Frame: 3 to 36 months ] [ Designated as safety issue: Yes ]The incidence of adverse events including events leading to patient death and hospitalizations
- Chemistry lab value change [ Time Frame: 3 to 36 months ] [ Designated as safety issue: Yes ]The change from baseline in chemistry measurements
| Enrollment: | 61 |
| Study Start Date: | June 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Paricalcitol
Pediatric patients receiving paricalcitol capsules to treat SHPT.
|
Drug: Paricalcitol
Pediatric patients receiving paricalcitol capsules to treat SHPT.
Other Name: ABT-358 Zemplar
|
|
Calcitriol
Pediatric patients receiving calcitriol to treat SHPT.
|
Drug: Calcitriol
Pediatric patients receiving calcitriol to treat SHPT
|
Eligibility| Ages Eligible for Study: | up to 16 Years |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
This is a multicenter, US only study of pediatric (0 to 16 years) males and females receiving peritoneal dialysis, treated in a routine clinical setting. Patients will be recruited from private nephrology practices or hospitals.
Criteria
Inclusion Criteria
- Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.
- 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.
- The patient is attending a site associated with NAPRTCS Dialysis Registry.
- 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.
- Patient has received paricalcitol or calcitriol for a minimum of 10 days.
Exclusion Criteria
- Patient is scheduled for a kidney transplant within 3 months.
- Patient is expected to stop peritoneal dialysis within 3 months.
- Patient is expected to transfer to hemodialysis within 3 months.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134315
Locations
| United States, Alabama | |
| Site Reference ID/Investigator# 37082 | |
| Birmingham, Alabama, United States, 35255 | |
| United States, Florida | |
| Site Reference ID/Investigator# 26762 | |
| Gainesville, Florida, United States, 32610 | |
| Site Reference ID/Investigator# 28529 | |
| Orlando, Florida, United States, 32801 | |
| United States, Georgia | |
| Site Reference ID/Investigator# 26748 | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Louisiana | |
| Site Reference ID/Investigator# 37582 | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, Maryland | |
| Site Reference ID/Investigator# 39973 | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Site Reference ID/Investigator# 26769 | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Site Reference ID/Investigator# 26768 | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Site Reference ID/Investigator# 26747 | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Ohio | |
| Site Reference ID/Investigator# 26749 | |
| Akron, Ohio, United States, 44308 | |
| Site Reference ID/Investigator# 26751 | |
| Cincinnati, Ohio, United States, 45229 | |
| Site Reference ID/Investigator# 26765 | |
| Columbus, Ohio, United States, 43205 | |
| United States, Oklahoma | |
| Site Reference ID/Investigator# 28528 | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Site Reference ID/Investigator# 26763 | |
| Portland, Oregon, United States, 97227 | |
| United States, Virginia | |
| Site Reference ID/Investigator# 28526 | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Site Reference ID/Investigator# 26758 | |
| Seattle, Washington, United States, 98105 | |
| United States, Wisconsin | |
| Site Reference ID/Investigator# 40382 | |
| Madison, Wisconsin, United States, 53792 | |
| Site Reference ID/Investigator# 26759 | |
| Wauwatosa, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
Investigators
| Study Director: | Tamara Marshall | AbbVie |
More Information
Additional Information:
Related Info 
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01134315 History of Changes |
| Other Study ID Numbers: | P12-053 |
| Study First Received: | May 28, 2010 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Evaluating incidence of hypercalcemia in pediatric patients |
Additional relevant MeSH terms:
|
Hypercalcemia Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Calcium Metabolism Disorders Metabolic Diseases Water-Electrolyte Imbalance Parathyroid Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency Calcitriol |
Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013