A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients

A Phase 3 Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of End Stage Renal Disease Treated With Hemodialysis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00037635

Enrollment

400

Registered

2002-05-20

Start date

2001-12-31

Completion date

2003-03-31

Last updated

2013-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Secondary Hyperparathyroidism

Brief summary

This 6 month long 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.

Interventions

DRUGAMG 073

30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

DRUGPlacebo

30 mg QD orally 60 mg QD orally 90 mg QD orally 120 mg QD orally 180 mg QD orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
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 (last 14 weeks of treatment)

Secondary

Measure	Time frame
To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in mean calcium x phosphorus product (Ca x P) during the efficacy assessment phase	efficacy assessment phase (last 14 weeks of treatment)
To evaluate the efficacy of AMG 073 compared with placebo by determining: changes in self-reported cognitive function from baseline to the end of the efficacy assessment phase	efficacy assessment phase (last 14 weeks of treatment)
To evaluate the safety of AMG 073 compared with placebo.	entire study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026