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.
(Terminated after FDA agreement.)
Sponsor:
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: May 17, 2013
Last verified: May 2013
  Purpose

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).


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:
  • Percentage of Participants With at Least One Incidence of Hypercalcemia [ Time Frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days). ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs [ Time Frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days). ] [ Designated as safety issue: Yes ]
    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.

  • Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ] [ Designated as safety issue: Yes ]
    Normal ranges for these chemistry measurements varied according to the age of the participant.

  • Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ] [ Designated as safety issue: Yes ]
    Normal ranges for these chemistry measurements varied according to the age of the participant.

  • Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV) [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ] [ Designated as safety issue: Yes ]
    Normal ranges for these chemistry measurements varied according to the age of the participant.

  • Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV) [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ] [ Designated as safety issue: Yes ]
    Normal ranges for these chemistry measurements varied according to the age of the participant.

  • Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV) [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ] [ Designated as safety issue: Yes ]
    Normal ranges for these chemistry measurements varied according to the age of the participant.

  • Mean Baseline and Change From Baseline in Albumin at Final Visit (FV) [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ] [ Designated as safety issue: Yes ]
    Normal ranges for these chemistry measurements varied according to the age of the participant.


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 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:
  • ABT-358
  • Zemplar
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

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

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  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: Ann Eldred, MD AbbVie
  More Information

Additional Information:
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
Results First Received: May 17, 2013
Last Updated: May 17, 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 April 15, 2014