Clinical trial NCT01134315: 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
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Secondary Hyperparathyroidism
End-Stage Renal Disease
Keywords: Evaluating incidence of hypercalcemia in pediatric patients
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
First posted: 2010-06-02
Enrollment: 61
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a multicenter, United States only study of pediatric (0 to 16 years) males and females receiving peritoneal dialysis, treated in a routine clinical setting. Patients were recruited from private nephrology practices or hospitals.

Brief 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).

Detailed description: Investigators were free to determine the appropriate therapy for each participant based on clinical judgment. Decisions to prescribe paricalcitol or calcitriol were made independently prior to enrollment of participants in this observational study.

Eligibility criteria: Inclusion Criteria:

1. Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.
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:

1. Patient is scheduled for a kidney transplant within 3 months.
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.

Primary outcomes:
measure: Percentage of Participants With at Least One Incidence of Hypercalcemia
timeFrame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
timeFrame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).
measure: Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
timeFrame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
measure: Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
timeFrame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
measure: Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)
timeFrame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
measure: Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)
timeFrame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
measure: Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)
timeFrame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
measure: Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)
timeFrame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 37082
state: Alabama
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 26762
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 28529
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 26748
state: Georgia
city: New Orleans
country: United States
facility: Site Reference ID/Investigator# 37582
state: Louisiana
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 39973
state: Maryland
city: Boston
country: United States
facility: Site Reference ID/Investigator# 26769
state: Massachusetts
city: Detroit
country: United States
facility: Site Reference ID/Investigator# 26768
state: Michigan
city: Kansas City
country: United States
facility: Site Reference ID/Investigator# 26747
state: Missouri
city: Akron
country: United States
facility: Site Reference ID/Investigator# 26749
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 26751
state: Ohio
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 26765
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 28528
state: Oklahoma
city: Portland
country: United States
facility: Site Reference ID/Investigator# 26763
state: Oregon
city: Charlottesville
country: United States
facility: Site Reference ID/Investigator# 28526
state: Virginia
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 26758
state: Washington
city: Madison
country: United States
facility: Site Reference ID/Investigator# 40382
state: Wisconsin
city: Wauwatosa
country: United States
facility: Site Reference ID/Investigator# 26759
state: Wisconsin
Study officials:
affiliation: AbbVie
name: Ann Eldred, MD
role: STUDY_DIRECTOR
References: