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

NCT01382212 | Completed Phase 3 Results

• 2 other identifiers: M11-6122013-002610-13
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 or hemodialysis 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.

Conditions

End-Stage Renal Disease; Secondary Hyperparathyroidism

Keywords

Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Hypercalcemia

  The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values \> 10.2 mg/dL (2.55 mmol/L).

  Day 1 to Week 12

Secondary Outcomes (20)

• Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL

  Baseline (last measurement collected prior to the first dose) to Week 12

• Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline

  Baseline (last measurement collected prior to the first dose) to Week 12

• Hemoglobin: Mean Change From Baseline to Final Visit

  Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

• Hematocrit: Mean Change From Baseline to Final Visit

  Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

• Red Blood Cells: Mean Change From Baseline to Final Visit

  Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Study Arms (1)

Paricalcitol

EXPERIMENTAL

Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Drug: paricalcitol

Interventions

paricalcitol DRUG

Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.

Also known as: ABT-358, Zemplar

Paricalcitol

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
• Subject is currently being diagnosed and/or 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 ≥ 8.2 and ≤ 10.4 mg/dL
• A phosphorus value ≤ 6.5 mg/dL
• An intact parathyroid hormone (iPTH) value \> 300 pg/mL and less ≤ 2000 pg/mL

You may not qualify if:

• 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 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (1)

• Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22.

  PMID: 28332096 RESULT

Related Links

• Prescribing Information

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperparathyroidism, Secondary

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

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; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Limitations and Caveats

The sample size of the study was limited to 13 subjects and there was no comparator group, so the study was not designed to analyze efficacy.

Results Point of Contact

• Title: Global Medical Information
• 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: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 27, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 2, 2018
• Results First Posted: November 21, 2016

Record last verified: 2016-11