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

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

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).

Study Overview

• Status: Terminated
• Conditions: End-Stage Renal Disease; Secondary Hyperparathyroidism
• Intervention / Treatment: Drug: Calcitriol; Drug: Paricalcitol

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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35255
      • Site Reference ID/Investigator# 37082
  • Florida
    • Gainesville, Florida, United States, 32610
      • Site Reference ID/Investigator# 26762
    • Orlando, Florida, United States, 32801
      • Site Reference ID/Investigator# 28529
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Site Reference ID/Investigator# 26748
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Site Reference ID/Investigator# 37582
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Site Reference ID/Investigator# 39973
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Site Reference ID/Investigator# 26769
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Site Reference ID/Investigator# 26768
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Site Reference ID/Investigator# 26747
  • Ohio
    • Akron, Ohio, United States, 44308
      • Site Reference ID/Investigator# 26749
    • Cincinnati, Ohio, United States, 45229
      • Site Reference ID/Investigator# 26751
    • Columbus, Ohio, United States, 43205
      • Site Reference ID/Investigator# 26765
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Site Reference ID/Investigator# 28528
  • Oregon
    • Portland, Oregon, United States, 97227
      • Site Reference ID/Investigator# 26763
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Site Reference ID/Investigator# 28526
  • Washington
    • Seattle, Washington, United States, 98105
      • Site Reference ID/Investigator# 26758
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Site Reference ID/Investigator# 40382
    • Wauwatosa, Wisconsin, United States, 53226
      • Site Reference ID/Investigator# 26759

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Paricalcitol; Other Names: Zemplar; ABT-358
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.	Drug: Calcitriol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Monitored from time of informed consent through end of study + 30 days (total of 745 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): June 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: May 17, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Evaluating incidence of hypercalcemia in pediatric patients
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Parathyroid Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcitriol
• Other Study ID Numbers: P12-053