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

AbbVie (prior sponsor, Abbott)61 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Secondary Hyperparathyroidism End-Stage Renal Disease

Interventions

ParicalcitolDRUG

Eligibility

Sex: ALLMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (18)

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

...and 8 more locations

Outcomes

Primary Outcomes

Percentage of Participants With at Least One Incidence of Hypercalcemia

Hypercalcemia was defined as calcium \>10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.

Time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).

Secondary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs

AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.

Time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).

Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)