Text Size

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

This study is currently recruiting participants.
Verified February 2013 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01439867
First received: September 22, 2011
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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: March 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 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)

  • 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

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:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

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: February 26, 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 May 21, 2013