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

This study has suspended participant recruitment.
(Dosing of IP was suspended due to a fatal case that occurred in the presence of severe hypocalcemia in an enrolled subject on a pediatric trial with the same IP)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01439867
First received: September 22, 2011
Last updated: August 27, 2013
Last verified: August 2013
  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:
  • Corrected serum calcium levels [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters at Week 12 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: June 2015 (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 or phosphate binders.
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 1820 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Screening plasma iPTH level > 300 pg/mL (31.8 pmol/L)
  • Screening serum calcium

    • 9.4 mg/dL (2.35 mmol/L) for subjects aged 28 days to < 2 years
    • 8.8 ( 2.2 mmol/L) for subjects aged 2 to < 6 years
  • Serum phosphorus

    • 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 year to < 6 years

Exclusion criterior:

  • SHPT not due to vitamin D deficiency, per investigator assessment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439867

  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: August 27, 2013
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
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 17, 2014