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

NCT01134315 | Terminated Results

• 1 other identifier: P12-053
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 18

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).

Conditions

Secondary Hyperparathyroidism; End-Stage Renal Disease

Keywords

Evaluating incidence of hypercalcemia in pediatric patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  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)

  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)

  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)

  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)

  Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

Study Arms (2)

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

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

Interventions

Paricalcitol DRUG

Also known as: ABT-358, Zemplar

Paricalcitol

Calcitriol DRUG

Calcitriol

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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 North America Pediatric Renal Trials and Collaborative Studies (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (18)

Site Reference ID/Investigator# 37082

Birmingham, Alabama, 35255, United States

Location

Site Reference ID/Investigator# 26762

Gainesville, Florida, 32610, United States

Location

Site Reference ID/Investigator# 28529

Orlando, Florida, 32801, United States

Location

Site Reference ID/Investigator# 26748

Atlanta, Georgia, 30322, United States

Location

Site Reference ID/Investigator# 37582

New Orleans, Louisiana, 70118, United States

Location

Site Reference ID/Investigator# 39973

Baltimore, Maryland, 21287, United States

Location

Site Reference ID/Investigator# 26769

Boston, Massachusetts, 02115, United States

Location

Site Reference ID/Investigator# 26768

Detroit, Michigan, 48201, United States

Location

Site Reference ID/Investigator# 26747

Kansas City, Missouri, 64108, United States

Location

Site Reference ID/Investigator# 26749

Akron, Ohio, 44308, United States

Location

Site Reference ID/Investigator# 26751

Cincinnati, Ohio, 45229, United States

Location

Site Reference ID/Investigator# 26765

Columbus, Ohio, 43205, United States

Location

Site Reference ID/Investigator# 28528

Oklahoma City, Oklahoma, 73104, United States

Location

Site Reference ID/Investigator# 26763

Portland, Oregon, 97227, United States

Location

Site Reference ID/Investigator# 28526

Charlottesville, Virginia, 22908, United States

Location

Site Reference ID/Investigator# 26758

Seattle, Washington, 98105, United States

Location

Site Reference ID/Investigator# 40382

Madison, Wisconsin, 53792, United States

Location

Site Reference ID/Investigator# 26759

Wauwatosa, Wisconsin, 53226, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Interventions

paricalcitol; Calcitriol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Ann Eldred, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 13, 2013
• Results First Posted: August 13, 2013

Record last verified: 2013-05

Locations

US (18)