Safety & Tolerability of Cinacalcet in Pediatric Subjects With Chronic Kidney Disease & Secondary Hyperparathyroidism

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01439867
First received: September 22, 2011
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

This is a multicenter, 26-week, single-arm, open-label, safety study. Subjects will remain on study for 26 weeks or until time of kidney transplantation, whichever comes first. All subjects, in addition to receiving cinacalcet, will receive standard of care, which may include vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs).


Condition Intervention Phase
Chronic Kidney Disease
Hyperparathyroidism, Secondary
Drug: Cinacalcet HCl
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Study to Assess the Safety & Tolerability of Cinacalcet in Addition to Standard of Care in Pediatric Subjects Age 28 Days to < 6 Yrs With Chronic Kidney Disease & Secondary Hyperparathyroidism Receiving Dialysis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Occurrence of corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) forages 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for ages ≥ 2 to < 6 years during the study [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Occurrence of corrected serum calcium < 8.8 mg/dL (2.2 mmol/L) during the study [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
  • PK parameters at week 12 (eg, maximum plasma concentration (Cmax), area under the curve (AUC), apparent clearance (CL/F), apparent volume of distribution (V/F)) [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
  • The percent change of plasma iPTH, corrected total serum calcium, serum phosphorous, and Ca x P from baseline to scheduled visits during the study [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
  • Achievement of ≥ 30% reduction from baseline in plasma iPTH during the study [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
  • Achievement of plasma iPTH values between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any two consecutive measurements [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]
  • Achievement of plasma iPTH values < 300 pg/mL (31.8 pmol/L) during the study [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinacalcet
100% receive Cinacalcet added to standard of care, which may include vitamin D sterols
Drug: Cinacalcet HCl
This is a multicenter, 26-week, single-arm, open-label, safety study. Subjects will remain on study for 26 weeks or until time of kidney transplantation, whichever comes first. All subjects, in addition to receiving cinacalcet, will receive standard of care, which may include vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs).
Other Name: Sensipar

  Eligibility

Ages Eligible for Study:   up to 2189 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L) from the central laboratory, and not have received any cinacalcet therapy for at least 30 days prior to start of dosing
  • Screening corrected total serum calcium from the central laboratory:

    • 9.4 mg/dL (2.35 mmol/L) if age 28 days to < 2 years
    • 8.8 (2.2 mmol/L) if age ≥ 2 to < 6 years
  • Serum phosphorus from the central laboratory:

    • 5.0 mg/dL (1.25 mmol/L) if age 28 days to < 1 year
    • 4.5 mg/dL (1.13 mmol/L) if age ≥ 1 to < 6 years
  • SHPT not due to vitamin D deficiency, per investigator assessment

Exclusion criterion:

  • History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
  • Corrected QT interval (QTc) > 500 ms, using Bazett's formula
  • QTc ≥450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist Use of grapefruit juice, herbal medications, or potent CYP 3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
  • Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439867

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 26 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01439867     History of Changes
Other Study ID Numbers: 20110100
Study First Received: September 22, 2011
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Dialysis
Sensipar
Mimpara
Hemodialysis
Peritoneal Dialysis
Renal
Parathyroid hormone
Pediatric

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency, Chronic
Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014