NCT00042653

Brief Summary

This 6 month study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2002

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

August 2, 2002

Last Update Submit

May 6, 2013

Conditions

Secondary HyperparathyroidismEnd Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.

    Efficacy Assessment phase - final 10 weeks of study

Secondary Outcomes (3)

  • To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase

    Efficacy Assessment phase - final 10 weeks of study

  • To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase

    Efficacy Assessment phase - final 10 weeks of study

  • To evaluate the safety of AMG 073 compared with placebo

    Entire study - 26 weeks

Study Arms (2)

AMG 073

EXPERIMENTAL

AMG 073

Drug: AMG 073

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PlaceboDRUG

30 mg of placebo taken once daily orally 60 mg of placebo taken once daily orally 90 mg of placebo taken once daily orally 120 mg of placebo taken once daily orally 180 mg of placebo taken once daily orally

Placebo
AMG 073DRUG

30 mg of AMG 073 taken once daily orally 60 mg of AMG 073 taken once daily orally 90 mg of AMG 073 taken once daily orally 120 mg of AMG 073 taken once daily orally 180 mg of AMG 073 taken once daily orally

AMG 073

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005 Mar;16(3):800-7. doi: 10.1681/ASN.2004060512. Epub 2005 Feb 2.

    PMID: 15689407RESULT

Related Links

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryKidney Failure, Chronic

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2002

First Posted

August 6, 2002

Study Start

May 1, 2002

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

May 8, 2013

Record last verified: 2013-05