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
This study is currently recruiting participants.
Verified April 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01382212
First received: June 24, 2011
Last updated: April 19, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.
| Condition | Intervention | Phase |
|---|---|---|
|
End-Stage Renal Disease Secondary Hyperparathyroidism |
Drug: paricalcitol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Hypercalcemia [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: Yes ]Incidence of hypercalcemia (two consecutive, post baseline corrected calcium measures greater than 10.2 mg/dL). This data will be gathered via blood draws.
Secondary Outcome Measures:
- Intact parathyroid hormone [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: No ]Proportion of subjects who achieve 2 consecutive intact parathyroid hormone values between 150 to 300 pg/mL (or greater than or equal to 30 percent reduction from baseline in intact parathyroid hormone).
- Changes from baseline in chemistry and hematology lab variables [ Time Frame: During the 12 week dosing period, up to week 12 ] [ Designated as safety issue: Yes ]
- Proportion of subjects experiencing adverse events [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: Yes ]
- Changes from baseline in electrocardiogram (ECG) [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: Yes ]
- Changes from baseline in vital signs [ Time Frame: From Day 1 to week 12 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paricalcitol
Open-label, active drug
|
Drug: paricalcitol
Capsules, open-label, single-arm
Other Name: Zemplar
|
Eligibility| Ages Eligible for Study: | 10 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject must be receiving peritoneal dialysis 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
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382212
Contacts
| Contact: Kim Grabbe, BS | 847-935-7838 | Kim.Grabbe@abbvie.com |
| Contact: Emily Kunka, MS | 847-937-7312 | emily.kunka@abbvie.com |
Locations
| United States, California | |
| Site Reference ID/Investigator# 48565 | Recruiting |
| Los Angeles, California, United States, 90095-1752 | |
| Principal Investigator: Site Reference ID/Investigator# 48565 | |
| Site Reference ID/Investigator# 55342 | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Principal Investigator: Site Reference ID/Investigator# 55342 | |
| United States, Florida | |
| Site Reference ID/Investigator# 48560 | Withdrawn |
| Miami, Florida, United States, 33155-4078 | |
| United States, Georgia | |
| Site Reference ID/Investigator# 53324 | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Site Reference ID/Investigator# 53324 | |
| United States, Missouri | |
| Site Reference ID/Investigator# 48570 | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Principal Investigator: Site Reference ID/Investigator# 48570 | |
| Site Reference ID/Investigator# 48555 | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Principal Investigator: Site Reference ID/Investigator# 48555 | |
| United States, Texas | |
| Site Reference ID/Investigator# 53326 | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Principal Investigator: Site Reference ID/Investigator# 53326 | |
| United States, Utah | |
| Site Reference ID/Investigator# 48566 | Recruiting |
| Salt Lake City, Utah, United States, 84113 | |
| Principal Investigator: Site Reference ID/Investigator# 48566 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Ann Eldred, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01382212 History of Changes |
| Other Study ID Numbers: | M11-612 |
| Study First Received: | June 24, 2011 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Parathyroid Diseases Endocrine System Diseases Urologic Diseases |
Renal Insufficiency Ergocalciferols Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013