Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children 10-16 With Chronic Kidney Disease (CKD). - Full Text View

Purpose

Safety and efficacy study using Paricalcitol capsules to decrease parathyroid hormone levels in children ages 10 to 16 with Chronic Kidney Disease.

Condition	Intervention	Phase
Chronic Kidney Disease Stage 3 and 4	Drug: Zemplar (paricalcitol) Capsules Drug: Placebo capsules	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 Years With Moderate to Severe Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Urine and Urination

Drug Information available for: Parathyroid Hormone Paricalcitol

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

The primary efficacy-endpoint is the proportion of subjects who achieve two consecutive greater than or equal to 30 percent reductions from baseline in intact parathyroid hormone levels. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
The primary efficacy measure for intact parathyroid hormone in pediatric Chronic Kidney Disease subjects is determined by the stage of Chronic Kidney Disease. The data is collected via blood draws.

Secondary Outcome Measures:

The proportion of subjects who achieve a final intact parathyroid hormone values within Kidney Disease Outcomes Quality Initiative intact parathyroid hormone target ranges will be evaluated within each Chronic Kidney Disease stage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
The proportion of subjects who achieve a final value within the applicable Kidney Disease Outcomes Quality Initiative target ranges for calcium. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
The proportion of subjects who achieve a final value within the applicable Kidney Disease Outcomes Quality Initiative target ranges for phosphorus. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12). [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12). [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12). [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
The mean percent change in intact parathyroid hormone from baseline to each post baseline visit (Weeks 2, 4, 8 and 12). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12). [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12). [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
The mean change in First Morning Void Urine Albumin/Creatinine Ratio from baseline to each post baseline visit (Weeks 4, 8 and 12). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	February 2010
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Paricalcitol capsules (1 - 3 mcg dose)	Drug: Zemplar (paricalcitol) Capsules Group 1 - Paricalcitol capsules 1 - 3 mcg TIW (one to three Paricalcitol 1 mcg capsules TIW).
Placebo Comparator: Placebo (1 -3 capsules per dose)	Drug: Placebo capsules Group 2 - Placebo TIW (one to three placebo capsules TIW)

Detailed Description:

The study consists of two parts. Part I is an open-label single-dose, non-fasting, multicenter study to evaluate the pharmacokinetics of paricalcitol capsules in 12 pediatric subjects ages 10 to 16 years with Chronic Kidney Disease Stages 3 and 4. Part II of this study will be conducted as a 12 week randomized double-blind, placebo-controlled study, followed by 12 weeks open-label treatment. Subjects active or enrolled under amendment 5 will enter a Follow-Up period and have study visits every 4 weeks until the final subject reaches Week 24. The objective of this multicenter study is to evaluate the safety and efficacy of paricalcitol capsules in decreasing serum intact parathyroid hormone levels to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative target goals in 36 pediatric subjects ages 10 to 16 years with Chronic Kidney Disease Stages 3 and 4.

Eligibility

Ages Eligible for Study:	10 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects' greater than or equal to 10 years old and less than or equal to 16 years old.
Subject has Chronic Kidney Disease Stage 3 or 4 as determined by estimated Glomerular Filtration Rate (15 to 59 mL/min/1.73 m2) at Screening.
Subject is not expected to begin dialysis for at least 6 months (in the opinion of the investigator).
To satisfy the Screening criteria (for subjects that are currently on a Vitamin D Receptor Activator and need to complete a 2 to 4 week washout), the subject must have:
- estimated Glomerular Filtration Rate between 15 to 59 mL/min/1.73 m2 (estimate by the Schwartz formula as outlined in Section 5.3.1.2).
- iPTH measurement that is greater than or equal to 60 pg/mL (Stage 3 subjects) or greater than or equal to 90 pg/mL (Stage 4 subjects).
- An adjusted serum calcium value greater than or equal to 8.2 mg/dL (2.05 mmol/L) to less than or equal to 10.5 mg/dL (2.63 mmol/L).
- A serum phosphorus value greater than or equal to 2.0 mg/dL (0.65 mmol/L but less than or equal to 6.0 mg/dL (1.94 mmol/L).
For entry into the Treatment Phase (Vitamin D Receptor Activator naïve subjects and those that have completed a 4 week washout), the subject must have:
- iPTH measurement that is greater than or equal to 75 pg/mL (Stage 3 subjects) or greater than or equal to 110 pg/mL (Stage 4 subjects).
- An adjusted serum calcium value greater than or equal to 8.4 mg/dL (2.10 mmol/L) but less than or equal to 10.2 mg/dL (2.55 mmol/L).
- A serum phosphorus value greater than or equal to 2.5 mg/dL (0.81 mmol/L) but less than or equal to 5.8 mg/dL (1.87 mmol/L).
- Must have Vitamin 25D level that is greater than or equal to 30 ng/mL (Part II Only).

Exclusion Criteria:

All subjects that have had a small bowel transplant will be excluded from the study.
Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined as an acute rise in serum creatinine).
Subject has had symptomatic or significant hypocalcemia requiring active Vitamin D therapy (for example, calcitriol, paricalcitol, doxercalciferol or alfacalcidol) within 6 months prior to the Screening Phase.
Subject has a history of active kidney stones (6 months prior to screening).
Subject has chronic gastrointestinal disease, which in the investigator's opinion may cause significant gastrointestinal malabsorption.
Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 weeks prior to Treatment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020487

Contacts

Contact: Kim Grabbe, BS	847-935-7838	Kim.Grabbe@abbvie.com
Contact: Emily Kunka, MS	847-937-7312	emily.kunka@abbvie.com

Show 47 Study Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Ann Eldred, MD

AbbVie

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01020487 History of Changes
Other Study ID Numbers:	M10-149, 2010-019439-37
Study First Received:	November 13, 2009
Last Updated:	April 19, 2013
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines Singapore: Health Sciences Authority United Kingdom: Medicines and Healthcare Products Regulatory Agency Portugal: National Pharmacy and Medicines Institute

Keywords provided by AbbVie:

Reduction of parathyroid hormone levels in pediatric patients with Chronic Kidney Disease Stage 3 and 4

Additional relevant MeSH terms:

Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Hormones
Ergocalciferols

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013