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

This study has been terminated.
(Decision made 17Feb16 to early terminate to provide full CSR for Nov16 US filing for pediatric indication.)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01439867
First received: September 22, 2011
Last updated: June 22, 2016
Last verified: June 2016
  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). Subjects who complete the 26-week study may be eligible to participate in an extension study (Study 20140159).

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:
  • Proportion of subjects who develop 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:
  • Proportion of subjects who develop 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 ]
  • Proportion of subjects who have any normal 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 ]
  • Proportion of subjects who have any decreases in IPTH of ≥ 30% from baseline at two consecutive measurements [ Time Frame: 3.5 years ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: June 2012
Study Completion Date: June 2016
Primary Completion Date: June 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   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects between the ages of 28 days to <6 years of age at enrollment (Czech Republic minimum age is ≥2 years of age at enrollment)
  • 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 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
    • Dry weight ≥ 7 kg at the time of screening

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

  Show 42 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01439867     History of Changes
Other Study ID Numbers: 20110100 
Study First Received: September 22, 2011
Last Updated: June 22, 2016
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:
Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2016