A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

• Conditions: - Stage 5 chronic kidney disease- Secondary to hyperparathyroidism; MedDRA version: 17.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2013-002610-13-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-14
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
•Male or female subject between 10 and 16 years of age, inclusive at the time of Screening
•Subject is currently being treated for secondary hyperparathyroidism
•For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor (VDR) Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:
?A corrected calcium value greater than or equal to 8.4 and less than or equal to 10.2 mg/dL
?A phosphorus value less than or equal to 6.5 mg/dL
?An intact parathyroid hormone value greater than 300 pg/mL and less than or equal to 2000 pg/mL
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
•Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)
•Subject is expected to transfer to chronic hemodialysis within 4 months of Screening (per investigator discretion)
•Subject has had a parathyroidectomy within 12 weeks prior to Screening
•Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
•Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing
•Subject is receiving cinacalcet at the time of Screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified