NCT00113958

Brief Summary

The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) to K/DOQI recommended targets in subjects with end stage renal disease (ESRD) receiving hemodialysis, on bio-intact parathyroid hormone, corrected serum calcium, serum phosphorus, and calcium phosphorus product.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2005

Completed
Last Updated

May 13, 2013

Status Verified

May 1, 2013

First QC Date

June 10, 2005

Last Update Submit

May 10, 2013

Conditions

End Stage Renal Disease

Keywords

End Stage Renal Disease (ESRD)secondary hyperparathyroidism (SHPT)hemodialysisbiPTHAMG 073, Amgen

Outcome Measures

Primary Outcomes (1)

  • Secondary hyperparathyroidism in people with kidney failure.

Secondary Outcomes (1)

  • Uncontrolled secondary hyperparathyroidism

Interventions

CinacalcetDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chertow GM, Blumenthal S, Turner S, Roppolo M, Stern L, Chi EM, Reed J; CONTROL Investigators. Cinacalcet hydrochloride (Sensipar) in hemodialysis patients on active vitamin D derivatives with controlled PTH and elevated calcium x phosphate. Clin J Am Soc Nephrol. 2006 Mar;1(2):305-12. doi: 10.2215/CJN.00870805. Epub 2006 Jan 25.

    PMID: 17699221RESULT

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicHyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2005

First Posted

June 13, 2005

Last Updated

May 13, 2013

Record last verified: 2013-05